Home

Urgent Medical Device Correction – 2955842

1. Instruments and Section 3 3 Table 3 3 Maximum ESU Power Table 3 3 Maximum ESU Power Settings to Stay Below the Monopolar Accessories User Settings to Stay Below 3kV Limit Instrument 3kV Limit for Approved ESUs and Monopolar Coag Modes Manual Instruments and Section 3 2 3 2 Special Configuration Instructions 3 2 Proper Configuration Instructions Accessories User Manual Instruments and Section 3 3 N A Added Recommended use of monopolar Cut mode section Accessories User Manual Recommended use of monopolar Cut mode 1 Any monopolar Cut mode can be used however use the lowest power setting that achieves the desired effect 2 Apply energy for the minimum time necessary to achieve the desired effect 3 Ensure that instrument tips are not glowing red and that there is not a blue plasma cloud surrounding the tips The power setting is too high if these indications are observed ISI P N 1012739 Rev B EU English Attachment C Page 3 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 3 3 N A Added Accessories User Bipolar instruments are rated for a maximum peak voltage of 500V Any Manual bipolar Coag mode is acceptable except Forced Coag on the ERBE VIO 300 D generator and Macro on the ConMed System 5000 generator Instruments and Section 3 3 N A Added in Table 3 3 Accessories User e In t
2. ISI P N 1012739 Rev B EU English Attachment C Page 11 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci S System Section 8 4 N A Added Figure 8 10 Grip Release Socket 8mm amp 5mm Instruments diagrams Manual da Vinci Si System Section A 2 Step 1 in Restarting the System During Added sentence to end of Step 1 in Restarting the System During a Procedure Manual a Procedure section section 1 Completely remove all instruments 1 Completely remove all instruments from the system The endoscope does from the system The endoscope does not need to be removed If an instrument is grasping tissue follow the grip not need to be removed release instructions in Chapter 9 Grip Release on page 9 13 da Vinci Si System Section 9 4 Step 2 in Emergency Grip Release Added to now Step 3 in Grip Release section Manual section 8 mm Clip Appliers and Harmonic Instruments Small Clip Appliers da Vinci S System Section 8 4 Step 2 in Emergency Grip Release Added to now Step 3 in Grip Release section Manual section 8 mm Clip Appliers and Harmonic Instruments Small Clip Appliers da Vinci Si System Section 9 4 N A Added Warning Manual WARNING Do not perform grip release on a non faulted system without first pressing the Emergency Stop button Failure to observe this warning may result in unintended instrume
3. ISI P N 1012739 Rev B EU English Attachment C Page 14 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci Si System Manual Section A 3 Conversion to Open Surgery Section A 3 Conversion to Open Surgerylf a situation arises where a conversion to open surgery is required perform the followingsteps to remove the system from the patient 1 Remove the instruments and endoscope from the patient 2 Disconnect the cannulae from the instrument and camera arms 3 Move the instrument and camera arms away from the patient Note If the system is in an error state while converting to open surgery the Patient Cart will still allow use of the port clutch buttons If the system loses all power the arms and setup joints may be overpowered to move the arms as necessary Updated Conversion to Open Surgery Section A 3 Conversion to Open Surgery If a situation arises where a conversion to open surgery is required perform the following steps to remove the system from the patient 1 Remove the instruments and endoscope from the patient Note the following Note Whenever possible use Surgeon Console control to release the instrument grips a In case of system failure while the instrument is grasping tissue the grips can be manually opened by following the grip release instructions see Grip Release on page 9 13 Chapter 9 Patient
4. diagrams Sterile Adapter Engagement Verification It is important to ensure the sterile adapter built into the drape is properly engaged with the instrument arm so the instrument works properly when installed Follow these steps and best practices to ensure engagement After the Sterile Adapter is attached and the discs rotate back and forth verify the position of the open notch on each disc Open Notch Location Top Left disc 7 o clock Top right disc 11 o clock Bottom right disc 3 o clock ISI P N 1012739 Rev B EU English Attachment C Page 32 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Bottom left disc 10 o clock Clockwise from top left 7 11 3 10 The discs should be in this alignment after draping and before installation of an instrument Note Once a sterile adapter is successfully engaged on the arm it should not need to be removed or reseated until the end of the procedure lf any open notch does not match the position above use the closed tip of a sterile Kelly Forceps or Hemostat instrument to manual rotate the disc Rotate the disc in either direction until it clicks into place The disc should no longer rotate once it is fully engaged If the sterile adapter does not engage properly remove amp reseat the instrument arm drape da Vinci Si System Manual Section 9 4 N A Ad
5. and preparation of vessels for arteriotomies These surgical tasks are precise and delicate In Instruments the scenario where the blades are used for more aggressive tasks i e to transect the uterus for removal there is a risk of damaging the blade or pulling the blade out of the snap fit ISI P N 1012739 Rev B EU English Attachment B Page 1 of 4 Urgent Medical Device Correction 2955842 05212014 002 C Attachment B Risk to Health Appendix instrument This could result in a sharp fragment falling into the patient Incorrect installation of the Tip Cover Accessory There are two key potential hazards that may result from incorrectly installing the tip cover First there is the potential of the instrument getting stuck in the cannula since an over installed tip cover causes the outer diameter of the instrument to be too large to fit down Improper Installation of Tip through the cannula Second if the tip cover has been over installed the tip cover can be Accessory pulled off the instrument during instrument removal and dropped in the patient These scenarios have the potential to cause harm if the difficulty inserting the instrument causes the instrument to stick and then slip forward into tissue or if the fallen tip cover is not identified and removed Instrument to instrument collision damages distal tip of instruments During a procedure if the distal end of an instrument being used is repeatedly colli
6. Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Manual Vessel Sealer User Section 1 5 WARNING Discontinue use if any Updated Warning WARNING Discontinue use if any damage or abnormality is Manual abnormality is observed during use observed during use Examples of instrument damage include broken or bent jaws scratches or cracks on the instrument shaft defects on the electrode sealing surface or cuts damage to the insulation on the wires Manual Location Original Change da Vinci Si System Section 7 4 Note To minimize fogging maintain Updated Note Manual heating of the endoscope tip by setting Note Both the Brightness slider video brightness and the Illuminator slider the Illuminator intensity to 100 and lamp intensity will affect the brightness of the image seen in the stereo adjust the brightness of the surgical viewer To minimize fogging maintain heating of the endoscope tip by setting image using the Illumination slider on the Illuminator slider to maximum and then adjust image brightness using the the touchpad or touchscreen under Brightness slider If working close to tissue decrease the Illuminator intensity Advanced Video Adjustments using the Illuminator slider and increase image brightness as necessary using the Brightness slider If the image is too dark check both the Illuminator and Brightness sliders making sure
7. EU English Attachment C Page 28 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes eend effector observed do not use the instrument In particular look for the following ethe tube insulation eCracks or damage on the end effector ecautery hook tip eCracks on shaft Broken energy cord connector Defects in the metal or plastic components of the accessory tip Permanent Cautery Hook Examine the permanent cautery hook before use If you observe cracks or other damage or if the tip appears loose do not use the instrument Examples of damage include defects on the hook tip cracks or damage to the piece connecting the tip to the shaft broken energy cord connector and cracks or scratches on the shaft Vessel Sealer User Section 2 3 N A Added Warning Manual WARNING Do not use any instrument to clean the Vessel Sealer inside the patient To clean the jaws intraoperatively see Intraoperative Cleaning on page 20 Vessel Sealer User Section 1 5 N A Added Warning Manual WARNING Do not use the Vessel Sealer on bone or other hard surfaces Vessel Sealer User Section 2 3 N A Added Warning Manual WARNING Use instruments with care Avoid contact between instruments inside the patient and do not use any instrument to apply force to another instrument inside the patient ISI P N 1012739 Rev B EU English Attachment C Page 29 of 48
8. English Attachment C Page 1 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Manual Location Original Change da Vinci Si System Section 1 4 a CAUTION The Intuitive Surgical a Updated Caution Manual electrosurgical instruments are CAUTION The Intuitive Surgical monopolar electrosurgical instruments are designed for use with a maximum peak designed for use with a maximum peak voltage of 3kV 6kV peak to peak Do voltage of 3kV 6kV peak to peak Do not use settings on the ESU that exceed a 3kV peak Do not attempt to use the not use settings on the ESU that exceed footswitch on the Surgeon Console with ESUs that are not compatible with the a 3kV peak Do not attempt to use the da Vinci Si System Consult with your Intuitive Surgical representative regarding footswitch on the Surgeon Console compatible models A table in the Instruments and Accessories User Manual with ESUs that are not compatible with lists compatible generators modes and maximum power settings to stay the da Vinci Si System Consult with below the 3kV peak limit your Intuitive Surgical representative regarding compatible models b Updated bulleted list second bullet For monopolar instruments always use the lowest output setting that achieves b Always use the lowest output setting the desired surgical effect while staying within 3kV maximum peak voltage that achieves the
9. Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci SiSystem Section 1 4 CAUTION The Intuitive Surgical CAUTION The Intuitive Surgical electrosurgical monopolar instruments are Manual electrosurgical instruments are designed for use with a maximum peak voltage of 3kV 6kV peak to peak Do designed for use with a maximum peak not use settings on the ESU that exceed a 3kV peak Do not attempt to use the voltage of 3kV 6kV peak to peak Do footswitch on the Surgeon Console with ESUs that are not compatible with the not use settings on the ESU that exceed da Vinci Si System Consult with your Intuitive Surgical representative regarding a 3kV peak Do not attempt to use the compatible models A table in the Instruments and Accessories User Manual footswitch on the Surgeon Console lists compatible generators modes and maximum power settings to stay with ESUs that are not compatible with below the 3kV peak limit the da Vinci Si System Consult with your Intuitive Surgical representative regarding compatible models Instruments and Section 3 3 N A Added in Table 3 3 Accessories User e In table columns Asterisk next to Megadyne Manual e Below the table Not approved for use with da Vinci Si Instruments and Section 19 1 N A Added Note Accessories User Manual Note To maintain pneumoperitoneum ensure that the cannula seal is firmly secured to th
10. Vision Cart labeled with gray text on a dull labeled with gray text on a dull background as those indicated by red boxes in background as those indicated by red Figure 4 15 above are connected as necessary by authorized ISI personnel boxes in Figure 4 15 above are when they install and or service the system Therefore no instructions are connected as necessary by authorized provided for connecting them in this user manual although the labels ISI personnel when they install and or themselves are described in Appendix G Symbols Icons and Text Messages service the system Therefore no Reference Do not unplug any of these connections instructions are provided for connecting them in this user manual although the labels themselves are described in Appendix G Symbols Icons and Text Messages Reference da Vinci Si System Section 5 2 N A Added Figure 5 2 Circuit breaker switches on I for main components Images Manual showing location look of main circuit breakers da Vinci Si System Section 5 2 Step 3 in Check AC Power Added to Step 3 in Check AC Power Connections section Connections 3 On the Vision Cart confirm that each of its component power switches for ISI P N 1012739 Rev B EU English Attachment C Page 9 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Manual 3 On the Vision Cart confirm that each the Core Came
11. WARNING Do not use this instrument to energize the tips of other instruments This may damage the end effectors or injure tissue inside or outside the field of view This damage could occur at points near the instrument tip or cannula Single Site OUS Manual Section 11 1 N A Added Warning WARNING Exercise caution when working with monopolar instruments close to other instruments Unintended energy may be delivered from the active monopolar instrument to a second instrument This could result in burns to tissue in contact with any of the second instrument s metal parts or its cannula To exercise caution in these scenarios the monopolar tip should be closer to the tissue than to the second instrument Single Site OUS Manual Section 12 1 Bullet Avoid contact with a monopolar instrument that may result in damage Updated bullet Avoid contact with an active monopolar instrument This may result in harm to the patient or damage to the ESU ISI P N 1012739 Rev B EU English Attachment C Page 47 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes to the ESU Vessel Sealer User Section 1 5 N A Added Warning Manual WARNING Exercise caution when working with monopolar instruments close to the Vessel Sealer Unintended energy may be delivered from the active monopolar instrument to the Vessel Sealer This could resul
12. Wrench that is being replaced by the Instrument Release Kit IRK With this Notice you are receving updated Labeling and the IRK Note The updated Labeling and IRK supersede any old versions of Labeling and the Emergency Grip Release Wrench All previous versions of these documents and the Emergency Grip Release Wrench should be discarded Intuitive Surgical has received a total of 66 unique adverse event reports associated with use scenarios that were not previously addressed in Labeling for the da Vinci Standard S Si or Si e Surgical System Instruments and Accessories Attachment B to this Notice summarizes those use scenarious into categories and the potential health consequences associated with each category of Labeling Affected Countries Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Columbia Cyprus Czech Republic Denmark Dominican Republic Egypt Finland France Germany Great Britain Greece Guadeloupe Hong Kong India Indonesia Iceland Ireland Israel Italy Luxembourg Japan Kuwait Lebanon Malaysia Mexico Monaco Netherlands New Zealand Norway Pakistan Philippines Panama Poland Portugal Puerto Rico Qatar Romania Russia Saudi Arabia Singapore Slovak Republic Slovenia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Taiwan Turkey Uruguay United States of America Venezuela and Vietnam Affected Labeling and IRK Please see Attachm
13. along the sheath and twist lock the luer Verify that the sheath is properly secured within the instrument by gently connector onto the female luer at the pulling back on the sheath exiting the instrument housing When properly back of the instrument secured no movement of the sheath will occur Instruments and Section 17 2 Step 7 in Assembly Instructions Updated Step 7 in Assembly Instructions section Accessories User section 7 Advance the sheath into the instrument until it extends past the tip Retract Manual 7 Advance the sheath into the the sheath slightly until it is just inside of the tip instrument until it extends 2 mm past the tip of the instrument Single Site OUS Section 7 1 Step 1 Added at the end of Step 1 Manual Insufflate the abdomen and insert the Insufflate the abdomen and insert the camera cannula using the blunt camera cannula using the blunt obturator When the cannula is at the correct insertion depth the top line on obturator the cannula will be level with the top of the Single Site port Single Site OUS Section 15 2 Step 3 in Intraoperative Use section Added to Step 3 in Intraoperative Use section Manual 3 Insert the obturator fully into the 3 Insert the obturator fully into the cannula Ensure that the obturator is cannula seated firmly against the seal the latches are fastened over the rim of the cannula and the tip of the obturator appears at the distal end of the cannula sleeve Single Site OUS Sect
14. assistant should squeeze the release levers on the sides of the instrument and pull the instrument out ISI P N 1012739 Rev B EU English Attachment C Page 42 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes the sides of the instrument and pull the instrument out then clear the sterile adapter da Vinci Si System Manual Section 9 4 WARNING The instrument may not be immediately visible when being moved from the cannula into the patient Use appropriate caution when manually inserting instruments into the patient Updated Warning WARNING The instrument may not be immediately visible when being moved from the cannula into the patient Move the endoscope to visualize the instrument and use appropriate caution when inserting instruments into the patient Accessories User Manual 4 Create a skin incision using standard surgical procedure Introduce the cannula and obturator assembly applying continuous controlled pressure on the obturator Manual Location Original Change da Vinci Si System Section 1 4 Third bullet Third bullet Manual Do not deliberately or unintentionally Do not deliberately or unintentionally use one instrument to energize other energize other endoscopic instruments endoscopic instruments Energizing other endoscopic instruments may cause Energizing other endoscopic tissue damag
15. by pressing Recover on the touchscreen or touchpad The Emergency Stop button illuminates when pressed and remains illuminated until the fault is recovered ISI P N 1012739 Rev B EU English Attachment C Page 13 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci S System Manual Section A 2 Emergency Stop Press the red Emergency Stop button on the right side pod of the Surgeon Console should it be necessary to stop system operation at any time When you press Emergency Stop the system classifies it as a recoverable fault which you can override by pressing Recover on the touchpad or touchscreen Changed Emergency Stop content Emergency Stop An EMERGENCY STOP button is provided on the right side pod of the Surgeon Console should system operation be required to stop at any time Press the red Emergency Stop button should it be necessary to stop system operation at any time The Emergency Stop button will cease robotic control of the instruments and endoscope The instruments and endoscope will stay in their last commanded position If the instrument grips are closed when the Emergency Stop button is pressed the grips will remain closed However the gripping force of the instrument may decrease Pressing Emergency Stop initiates a recoverable fault which you can override by pressing FAULT OVERRIDE on the touchscreen or touchpad
16. content for Manual ConMed System 5000 Instruments and Section 3 3 Table 3 3 Maximum ESU Power Table 3 3 Maximum ESU Power Settings to Stay Below the Monopolar Accessories User Settings to Stay Below 3kV Limit Instrument 3kV Limit for Approved ESUs and Monopolar Coag Modes Manual Instruments and Section 3 3 The corresponding maximum ESU Updated to Accessories User power settings to stay below the 3kV The approved ESUs Monopolar Coag Modes and corresponding maximum ESU Manual limit are as follows power settings to stay below the monopolar instrument 3kV limit are as follows Do not use an unapproved ESU or unlisted monopolar coag mode Single Site OUS Section 10 2 N A Added Note under Monopolar Cautery Settings section Manual Note Refer to the Instruments and Accessories User Manual PN 550675 for appropriate instrument cord connections and for proper setup instructions pertaining to use of the ERBE ICC 350 ERBE VIO 300D and Covidien Force Triad generators Single Site OUS Section 15 2 Step 2 in Intraoperative Use section Added to Step 2 in Intraoperative Use section Manual 2 Using sterile technique attach the appropriate sterile cannula seal to the cannula 2 Using sterile technique attach the appropriate sterile cannula seal to the cannula For the curved cannulae and 10 mm Accessory Cannula ensure that the seal is visibly seated around the circumference of the cannula bowl For the 5 mm Accessory Cannula tw
17. desired surgical Maximum power levels to stay below this limit are listed in a table in the effect Instruments and Accessories User Manual da Vinci Si System Section 4 4 Step 1 in To connect an auxiliary Added to Step 1 in To connect an auxiliary device section Manual device section 1 Plug the auxiliary device end of the cable into the corresponding channel s 1 Plug the auxiliary device end of the on the device Tighten the screw lock completely to ensure that the cable is cable into the corresponding channel s fully connected on the device da Vinci SiSystem Section 4 4 Step 2 in To connect an auxiliary Added to Step 2 in To connect an auxiliary device section Plug the system device section Plug the system end end of the cable into any of the three Energy receptacles on the back of the ISI P N 1012739 Rev B EU English Attachment C Page 2 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Manual of the cable into any of the three Energy receptacles on the back of the Core Figure 4 14 Core Figure 4 14 Align the red dot on the cable connector with the red dot to the right of the receptacle You should hear an audible click when the cable engages properly Gently pull on the cable connector to verify that the cable is fully seated When the ESU and system are turned on the corresponding LED indicator will turn on
18. each is far enough to the right given the working distance of the endoscope tip from tissue da Vinci SiSystem Section 7 4 N A In Advanced Video Adjustments added bullet Restore Factory Settings Touch to restore all advanced video adjustments to default values which should be appropriate for most clinical scenarios Manual Location Original Change ISI P N 1012739 Rev B EU English Attachment C Page 30 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci Si System Section 9 4 Instrument Removal Steps 1 Before Updated Instrument Removal steps Manual instrument removal the Surgeon Console operator should do the 1 Before instrument removal the Surgeon Console operator should do the following a Ensure the instrument tip following is free and clear of any patient anatomy b Straighten the instrument wrist c Open the instrument jaws b Straighten the instrument wrist instrument removal is difficult with jaws closed d Clearly communicate to the Patient Cart operator which a Ensure that the instrument tip is in view and is free of any patient anatomy c Clearly communicate to the patient side assistant which instrument to remove Identify the name of the instrument or the number of the instrument instrument to remove Identify the armi egu intrument armii 2 2 name of the instrument or the number 2 Once the
19. though the cannula Follow steps 9 11 to re install the instrument ISI P N 1012739 Rev B EU English Attachment C Page 23 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 13 2 Step 4 in Blade Protector section Added sentence to Step 4 in Blade Protector section Accessories User 4 Immediately before removing a 4 Immediately before removing a scalpel instrument slide the blade protector Manual scalpel instrument slide the blade through the cannula seal towards the instrument tip Be sure to remove the protector through the cannula seal blade protector along with the instrument If the blade protector remains in towards the instrument tip the cannula seal loss of insufflation will occur Instruments and Section 17 2 Step 10 in Assembly Instructions Added to Step 10 in Assembly Instructions section Accessories User section 10 Under endoscopic visualization advance the sheath until it protrudes Manual 10 Advance the fiber until it protrudes approximately 2mm from the tip of the instrument Advance the fiber until it 1 2 mm from the tip of the laser protrudes 1 2 mm from the tip of the laser sheath sheath Instruments and Section 17 2 Step 11 in Assembly Instructions Added to Step 11 in Assembly Instructions section Accessories User section 11 Tighten the proximal and sliding Touhy Borst adapters when de
20. until the handle of the obturator is seated firmly against the seal assembled with the Intuitive cannula and the tip of the obturator appears at the distal end of the cannula sleeve To use attach the disposable seal assembly securely to the top of the cannula Insert the obturator through the seal into the cannula until the handle of the obturator is seated firmly against the seal and the tip of the obturator appears at the distal end of the cannula sleeve Instruments and Section 22 2 Step 1 in 22 2 Instructions for Use Added to Step 1 in 22 2 Instructions for Use section Accessories User Manual section 1 Attach the seal to the reducer by aligning it axially with the reducer and sliding the pins of the cannula reducer into the slots on the seal Rotate the seal clockwise to lock into place See Figure 22 1 1 Attach the seal to the reducer by aligning it axially with the reducer and sliding the pins of the cannula reducer into the slots on the seal Rotate the seal clockwise to lock into place You will hear a click once the cannula seal is locked in place See Figure 22 1 ISI P N 1012739 Rev B EU English Attachment C Page 36 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 3 3 Table 3 3 Edited Table 3 3 Accessories User Changed all instances of ValleyLab to Covidien and updated
21. with monopolar instruments arcs and alternate site burns See Table Doing so may result in electrical arcs and alternate site burns See Table 10 4 10 4 below for maximum ESU power below for maximum ESU power settings to stay below this limit Do not use any settings to stay below this limit Do not generator or monopolar coag mode not listed use any generator or monopolar coag mode not listed Manual Location Original Change ISI P N 1012739 Rev B EU English Attachment C Page 8 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci SiSystem Section 4 N A Added Note Note The only connections you should access on the back of the Manual Vision Cart are the power cords blue system cables auxiliary device cables and audio video cables as described in this chapter Other cables on the back of the Vision Cart should remain connected at all times and should only be accessed by authorized ISI personnel da Vinci Si System Section 4 5 N A Figure 4 15 Added green highlight box around the video out and audio in out Manual sections too This way anything the user can touch is green and anything they can t is red da Vinci Si System Section 4 5 Note Connectors on the Core and Added to Note Do not unplug any of these connections Manual other components on the Vision Cart Note Connectors on the Core and other components on the
22. 01 550526 02_A 551096 02_A 381263 01 French France Belgium Switzerland Monaco Guadeloupe Luxembourg 550656 06_A 551063 05_A NA 550681 05_A 551279 06_A 552608 01_A 552640 01 552667 01 552693 01 552719 01 552745 01 550523 04_A 551097 02_A 381264 01 French Canada Canada 550656 06_A NA NA 550681 05_A NA NA 552640 01 552667 01 552693 01 552719 01 552745 01 550523 04_A 551097 02_A 381264 01 German Germany Belgium Switzerland Austria Luxembourg 550657 06_A 551064 05_A NA 550682 05_A 551280 06_A 552609 01_A 552641 01 552668 01 552694 01 552720 01 552746 01 550522 04_A 551098 02_A 381265 01 Greek Greece Cyprus 550658 06_A 551065 05_A NA 550683 05_A 551281 06_A 552610 01_A 552642 01 552669 01 552695 01 552721 01 552747 01 550527 03_A 551099 02_A 381266 01 Italian Switzerland Italy 550659 06_A 551067 05_A NA 550684 05_A 551283 06_A 552612 01_A 552644 01 552671 01 552697 01 552723 01 552749 01 550520 04_A 551101 02_A 381268 01 ISI P N 1012739 Rev B EU English Attachment D FSCA 2955842 05212014 002 C Page 1 of 2 Urgent Medical Device Correction 2955842 05212014 002 C Attachment D Affected Manuals IFU s QRG s and IRK by Language a
23. 2 in Generator Settings Connect Added to Step 2 in Generator Settings Connect the Gyrus ACMI generator to Accessories User Manual the Gyrus ACMI generator to the plug connector on the PK Dissecting Forceps using the appropriate configuration as shown below the plug connector on the PK Dissecting Forceps using the appropriate configuration as shown below Table 7 1 PK Instrument Cord Configuration ISI PK Instrument Cord PN 400229 Gyrus ACMI Generator Type G400 Generator a Minimum recommended software level for Gyrus ACMI G400 is v1 08 Verify that the plug is fully inserted by confirming that the base is flush with the connector on the instrument housing ISI P N 1012739 Rev B EU English Attachment C Page 39 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 3 3 Step 3 in Electrosurgical Unit ESU Added to Step 3 in Electrosurgical Unit ESU Preparation section Accessories User Preparation section Connect the ESU to the EndoWrist instrument using the appropriate Manual Connect the ESU to the EndoWrist monopolar bipolar instrument cord Instrument energy cords are properly instrument using the appropriate connected to the instruments when the connector completely covers the monopolar bipolar instrument cord exposed pins Refer to the ESU s manual for indications and instructions in R
24. 3_B 381199 01 Bulgarian Bulgaria 550651 06_A 551056 04_A NA 550676 05_A 551271 06_A 552600 01_A 552632 01 NA 552685 01 552711 01 552737 01 550537 02_A 551090 02_A 381256 01 Simplified Chinese China Hong Kong 550667 06_A 551057 03_A NA 550692 05_A 551272 06_A 552601 01_A 552633 01 552660 01 552686 01 552712 01 552738 01 550524 02_A 551091 02_A 381257 01 Traditional Chinese Taiwan 551118 05_A 551383 03_A NA 551125 04_A 551273 06_A 552602 01_A 552634 01 552661 01 552687 01 552713 01 552739 01 551528 02_A 552763 01_A 381258 01 Czech Czech Republic 550652 06_A 551059 04_A NA 550677 05_A 551275 06_A 552604 01_A 552636 01 552663 01 552689 01 552715 01 552741 01 550525 02_A 551093 02_A 381260 01 Danish Denmark 550653 06_A 551060 05_A 550678 05_A 551276 06_A 552605 01_A 552637 01 552664 01 552690 01 552716 01 552742 01 550518 04_A 551094 02_A 381261 01 Dutch Belgium Netherlands 550654 06_A 551061 05_A NA 550679 05_A 551277 06_A 552606 01_A 552638 01 552665 01 552691 01 552717 01 552743 01 550517 04_A 551095 02_A 381262 01 Finnish Finland 550655 06_A 551062 04_A NA 550680 05_A 551278 06_A 552607 01_A 552639 01 NA 552692 01 552718 01 552744
25. 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 4 1 N A Added Warning Accessories User Section 5 1 WARNING Do not use this instrument to energize the tips of other Manual Section 16 1 instruments This may damage the end effectors or injure tissue inside or outside the field of view Tissue damage could occur at points near the tip or at the port site cannula of the energized instrument Instruments and Section 4 1 N A Added under General Precautions and Warnings Accessories User Exercise caution when working with monopolar instruments close to other Manual instruments Unintended energy may be delivered from the active monopolar instrument to a second instrument This could result in burns to tissue in contact with any of the second instrument s metal parts or its cannula To exercise caution in these scenarios the monopolar tip should be closer to the tissue than to the second instrument Instruments and Section 5 2 N A Added Warning Accessories User Section 16 1 WARNING Exercise caution when working with monopolar instruments close Manual to other instruments Unintended energy may be delivered from the active monopolar instrument to a second instrument This could result in burns to tissue in contact with any of the second instrument s metal parts or its cannula To exercise caution in these scenarios the monopolar tip sho
26. 5 01 NA 552707 01 552733 01 552759 01 550564 02_A 551110 02_A 381278 01 Spain Mexico Argentina Chile l Venezuela Spanish Colombia Uruguay Dominican Republic Puerto Rico Panama 550668 06_A 551077 04 A NA 550693 05_A 551294 06 A 552623 01_A 552656 01 552682 01 552708 01 552734 01 552760 01 550521 04 A 551111 02_A 381279 01 Sweden Swedish Finland 550669 06_A 551078 04_A NA 550694 05_A 551295 06_A 552624 01_A 552657 01 552683 01 552709 01 552735 01 552761 01 550519 04_A 551112 02_A 381280 01 Turkish Turkey 550670 06_A 551079 05 A NA 550695 05 A 551296 06_ A 552625 01_A 552658 01 552684 01 552710 01 552736 01 552762 01 550534 02 A 551113 02_A 381281 01 Vessel Sealer labeling not available in this country Includes separate documentation for Single Site reprocessing Documentation includes updated reprocessing instructions in anticipation of new product introductions ISI P N 1012739 Rev B EU English Attachment D FSCA 2955842 05212014 002 C Page 2 of 2
27. 55842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci S System Section 8 4 N A Added Grip Release Warning Manual WARNING Do not reuse an instrument that has had its grip released with the instrument release kit Reusing an instrument after use of the instrument release kit could result in critical failure of the instrument and injury to the patient da Vinci S System Section A 3 N A Added Note Manual If the system is in a fault state while converting to open surgery the Patient Cart will still allow use of the port clutch buttons If the system loses all power the arms and setup joints may be overpowered to move the arms as necessary da Vinci S System Section 11 2 N A Added Section Instrument Release Kit Manual Instrument Release Kit Clean and sterilize the instrument release kit in the same way as the grip release tool For grip release tool cleaning and sterilization instructions refer to the Reprocessing Instructions PN 550875 da Vinci S System Section A 3 N A Conversion to Open Surgery section added information for disconnecting Manual cannulae and moving the instrument and camera da Vinci S System Section 8 4 N A Updated Grip Release section Manual e Referenced Emergency Stop section in Appendix A e Updated procedure to release the grips da Vinci Si System Section 9 4 N A Added Figure 9 13 Grip Release Socket 8mm amp 5mm Instruments diagrams Manual
28. Cart Use WARNING Do not perform grip release on a non faulted system without first pressing the Emergency Stop button Failure to observe this warning may result in unintended instrument motion or damage to the grip release mechanism WARNING Rotating the grip release tool too far and or in the incorrect direction can cause unintended instrument motion or damage to the grip release mechanism 2 Disconnect the cannulae from the instrument and camera arms 3 Move the instrument and camera arms away from the patient Note If the system is in a fault state while converting to open surgery the Patient Cart will still allow use of the port clutch buttons If the system loses all power the arms and setup joints may be overpowered to move the arms as necessary ISI P N 1012739 Rev B EU English Attachment C Page 15 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci Si System Section A 3 Conversion to Open Surgery A 3 Conversion to Open Surgery Manual Section A 3 Conversion to Open If a situation arises where a conversion to open surgery is required perform the Surgerylf a situation arises where a following steps to remove the system from the patient conversion to open surgery is required 1 Remove the instruments and endoscope from the patient Note the perform the followingsteps to remove folwine Note Whenever possible use Surgeon C
29. Correction 2955842 05212014 002 C Attachment B Risk to Health Appendix In the case where a user in not trained or familiar with instrument removal it could be perceived that the instrument is stuck on the arm If there is confusion this could lead to moving the arm when attempting to remove the instrument or even conversion of the procedure to an alternative surgical method Damaged Cables Failure of component connection cables Blue fiber cable The da Vinci system has multiple components that need to be powered and properly connected for the system to be used The main system components Surgeon console Patient cart and Vision cart are connected by a fiber optic cable If this cable is poorly managed and it exposed to abuse rolled over by OR equipment etc then parts of the system are not able to communicate and the system is unable This can cause a procedure to abort post anesthesia and possibly post port placement depending on when the damage is identified Installation and Use of Sterile Adapters and Drapes Improper engagement of the Sterile Adapter to the system or instrument The sterile adapter is needed to transfer motion from the robotic arm to the instrument inputs in order to operate the instrument If the engagement between the sterile adapter and the arm is incomplete it can cause non intuitive motion of the instrument Before the issue is identified unintended tissue damage can occur due to the non intui
30. Date 17 November 2014 Field Safety Notice Urgent Medical Device Correction 2955842 05212014 002 C Labeling Update for da Vinci Standard S Si and Si e Surgical Systems Instruments and Accessories Dear da Vinci Customer The purpose of this Urgent Medical Device Correction is to advise you that Intuitive Surgical is initiating a voluntary correction related to labeling updates to distributed User Manuals Instructions for Use IFU Quick Reference Guides QRG collectively referred to herein as Labeling and the Natural Rubber Latex NRL QRG as well as an Instrument Release Kit IRK for use with da Vinci Surgical Systems Instruments and Accessories The Labeling updates have been implemented to incorporate user feedback This correction does not impact the performance of the da Vinci Standard S or Si Surgical Systems its instruments or accessories This correction does not apply to the da Vinci Xi Surgical System An Intuitive Surgical Representative will provide an in service visit to review the labeling changes outlined in Attachment A that could have more significant implications on patient safety User feedback addresses various product use scenarios and these scenarios and their potential implications on patient safety are outlined in Attachment B A detailed list of all labeling changes is provided in Attachment C No product removal is required with the exception of the removal of the old Emergency Grip Release
31. TION lt mail merge field gt By signing this form acknowledge that have received read and understand the content of this Urgent Medical Device Correction and Attachments confirm completion of the following actions 1 Ihave ensured all appropriate personnel are fully informed of the contents of this Notice 2 Ihave reviewed the labeling changes and related information as outlined in Attachments A B and C 3 Ihave identified the old Emergency Grip Release Wrench PN 710142 and have replaced it with the Instrument Release Kit IRK confirm that have discarded the old Emergency Grip Release Wrench 4 Ihave received an in service of the information in Attachment A conducted by an Intuitive Surgical Representative Name print Position Signature Cc Robotics Coordinator Co Operating Room Director Hospital Name CJ Risk Manager Phone Number n LO Recall Coordinator CJ Other Email Bee Date PLEASE RETURN THIS ACKNOWLEDGEMENT FORM TO Intuitive Surgical Inc WITHIN TWO DAYS OF IN SERVICE ATTN REGULATORY COMPLIANCE Subject line for email Labeling Update U S Fax 1 408 716 3040 or Scan and Email isi compliance intusurg com Please contact Customer Service if you have additional questions e North and South America 800 876 1310 Option 3 6 am to 5pm PST e Japan 0120 56 5635 or 03 5575 1362 9 am to 6 pm JST e South Korea 02 3271 3200 9am to 6pm KSTJ e Europe Middle East India Africa and A
32. a Installed beyond orange surface bulge AN j Iim aA Oo d 4 Figure 4 Tip Cover over installed A WARNING Failure to install the Tip Cover Accessory properly may result in e Improper scissor opening Tip Cover Accessory falling off e Electrical arcs and alternate site burns ISI P N 1012739 Rev B EU English FSCA 2955842 05212014 002 C Page 6 of 7 Date 17 November 2014 Urgent Medical Device Correction 2955842 05212014 002 C Attachment B Risk to Health Appendix Attachment C Identification of Labeling Changes Attachment D Affected Manuals IFU s QRG s and IRK by Language and Country ISI P N 1012739 Rev B EU English FSCA 2955842 05212014 002 C Page 7 of 7 Urgent Medical Device Correction 2955842 05212014 002 C Attachment B Risk to Health Appendix i Use of non compatible ESUs Intuitive Surgical has validated a series of 3 party ESUs for use with the da Vinci systems When the generator is validated the energy output is characterized so that max settings can be communicated to the user along with guidance on compatible modes Since many generators use common plug configurations Intuitive Surgical s EndoWrist instruments can be connected to generators that have not been validated In this case there is the scenario of using settings and modes that are not compatible with the system These scenarios are discussed further below Improper Electrosurgical Use of incorrect cautery mo
33. able columns Asterisk next to Megadyne Manual e Below the table Not approved for use with da Vinci Si Instruments and Section 3 2 N A Added label AUS OFF must be lit and pointer arrows for Figure 3 1 Accessories User Sentence added Ensure that the Auto Start Off indicator is lit see Figure 3 1 Manual If the Auto Start Off indicator AUS OFF is not lit press the arrow button below it to select it Instruments and Section 3 3 CAUTION Please refer to the individual Added to Caution Any bipolar coag mode is acceptable Accessories User ESU manufacturer s Operator s CAUTION Please refer to the individual ESU manufacturer s Operator s Manual Manuals for operating instructions Set Manuals for operating instructions Set the ESU to bipolar output Any bipolar the ESU to bipolar output Set the coag mode is acceptable except Forced Coag on the ERBE VIO 300 D generator power as low as possible to achieve and Macro on the ConMed System 5000 generator Set the power as low as adequate hemostasis possible to achieve adequate hemostasis Instruments and Section 3 2 Step 3 in To Select Single Footswitch Added to Step 3 in To Select Single Footswitch for BIPOLAR 3 On the next Accessories User Manual for BIPOLAR 3 On the next screen select the upper left soft button for single footswitch When selected the circle next to the soft button is filled green as shown screen select the upper left soft button for single f
34. achment A In Service Checklist Tip Cover Accessory Installation Before Use The Tip Cover Accessory is provided in a sterile pouch for a single use Install the Tip Cover Accessory onto the instrument in the sterile field 1 Close the scissor blades 2 Straighten the wrist of the instrument See Figure 1 below 3 Grasping the Tip Cover Accessory with the Installation Tool as shown in Figure 1 slide the Tip Cover Accessory onto the distal end of the instrument until it comes to a stop A twisting motion can be used to ease installation The distal end of the instrument should be facing away from you during installation Figure 1 Sliding the Tip Cover Accessory onto the instrument 4 Remove the Installation Tool and retain it to aid in removing the Tip Cover Accessory after use The Tip Cover Accessory is properly installed when the orange surface is completely covered See Figure 2 Tip cover Instrument main shaft Figure 2 Properly installed Tip Cover Accessory in place The Tip Cover Accessory is not properly installed if any part of the orange surface is visible as shown in Figure 3 ISI P N 1012739 Rev B EU English FSCA 2955842 05212014 002 C Page 5 of 7 Date 17 November 2014 Figure 3 Tip Cover Accessory not properly installed It is also not properly installed if installed beyond the orange surface and over the shaft This causes a bulge on the shaft and may prevent it fitting through the cannul
35. ase grips with manual grip release The EndoWrist instruments have a hex socket on the top of the instrument input disk and a corresponding hex wrench that can be used in the event that the system faults and the user needs to manually release grasped tissue However the system needs to be in a fault state in order for release to work motors need to be in soft lock Otherwise the system motors cannot be over driven by the wrench If the user does not know to press e stop if the system is not in a faulted state they will not be able to move the grips with the wrench to release the g tissue This could result in unintended tissue damage and potential delays in converting a Procedure for Converting r procedure if necessary While Instrument is Grasping Tissue N gt Wrong instrument arm moved during conversion Frequently in a case the patient side assistant is instructed by the surgeon to exchange instruments or move an arm of the system In the case of a conversion the patient side assistant would be tasked with clearing the instruments and arms from the surgical field If the patient side assistant removes or moves the incorrect instrument it could cause unintended tissue damage This is especially likely if the instrument mistakenly moved was grasping tissue at the time Use of Snap Fit blades outside of intended use The paddle instrument and 15 degree blades were specifically designed for use in dissection Unintended Use of
36. ase of system failure while this instrument is grasping tissue the grips can Manual the grasping jaw can be opened manually by inserting the emergency grip release or Allen wrench into the proximal hole in the instrument housing and turning counter clockwise to release be manually opened by inserting the grip release tool into the grip release hole in the instrument housing and carefully turning clockwise Squeeze the release levers and withdraw the instrument Use visualization of surgical site when inserting the grip release wrench opening jaws clearing jaws from tissue and removing the instrument from the system ISI P N 1012739 Rev B EU English Attachment C Page 18 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 2 1 WARNING In case of system failure Updated Warning Accessories User while the instrument is grasping tissue WARNING In case of system failure while the instrument is grasping tissue the Manual the grip jaw can be opened manually grips can be manually opened by inserting the grip release tool into the grip by inserting the emergency grip release release hole in the instrument housing and carefully turning Squeeze the or an Allen wrench into the proximal release levers and withdraw the instrument Use visualization of surgical site hole in the instrument housing when inserting the gri
37. carbonized tissue remove Manual the instrument and wipe the blades with a piece of moistened sterile gauze to remove the tissue Do not use another instrument to clean the blades Instruments and Section 5 2 N A Added Accessories User Section 16 2 During use if the tip becomes contaminated by carbonized tissue remove the Manual instrument and wipe the tip with a piece of moistened sterile gauze to remove the tissue Do not use another instrument to clean the tip Vf ISI P N 1012739 Rev B EU English Attachment C Page 26 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 8 1 Bullet Added to Bullet Accessories User Blood and tissue buildup between the To prevent burn injury remove any visible tissue buildup at the distal end of Manual blade and insert may result in the insert by removing the instrument and wiping with moist sterile gauze abnormally high temperatures at the distal end of the insert To prevent burn injury remove any visible tissue buildup at the distal end of the insert Instruments and Section 2 2 N A Added Warning Accessories User WARNING Do not use an instrument to clean debris from another instrument Manual inside the patient This may result in damage to the instruments or other unintended consequences such as disconnection of the instrument tip To clean an instrument intraoperat
38. d Step 3 section Manual a Delete monopolar in first sentence a Delete monopolar in first sentence b Connect the ESU to the Single Site b Connect the ESU to the Single Site instrument using the appropriate instrument using the appropriate instrument cord Refer to the ESU s manual for indications and instructions in instrument cord Refer to the ESU s making this connection Ensure that the monopolar instrument cord is plugged manual for indications and instructions into the monopolar receptacle on the ESU and that the bipolar instrument in making this connection cord is plugged into the bipolar receptacle on the ESU Instrument energy cords are properly connected to the instruments when the connector completely covers the pins Manual Location Original Change da Vinci Si System Section 9 4 N A Added Warning Manual WARNING Use appropriate caution when inserting instruments into the patient by visualizing the instrument on the touchscreen as it is being inserted INTUITIV ISI P N 1012739 Rev B EU English Attachment C Page 41 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci Si System Section 9 4 CAUTION Removal of instruments Updated Caution CAUTION Removal of instruments during a procedure should Manual during a procedure should be done be done very carefully and only with the knowledg
39. d objects in Intraoperative Use section Single Site OUS Section 9 1 Bullet Updated bullet Manual Do not use an instrument to clean Do not use an instrument to clean debris from another instrument inside the debris from another instrument patient This may result in damage to the instruments or other unintended intraoperatively This may result in consequences such as disconnection of the instrument tip To clean an damage to the instruments or other instrument intraoperatively remove the instrument from the system and unintended consequences such as wipe the tips with sterile moistened gauze disconnection of the instrument tip Single Site OUS Section 15 2 In Inspection Instructions section Updated In Inspection Instructions section Manual Before use inspect the cannulae and Before use inspect all cannulae and obturators for damage or defects obturators for damage or defects Examples of cannula damage include rough edges dents an out of round shape or a bent cannula shaft For more information see Curved Cannula Inspection on page 53 Single Site OUS Section 11 2 Inspection Before Use section Updated Inspection Before Use section Manual Inspection Before Use Examine the instrument before use In particular examine the following components for cracks or flaws Inspection Before Use Monopolar Cautery Instrument Examine the monopolar cautery instrument before use If any damage is ISI P N 1012739 Rev B
40. d tissue structures before the incorrect connections are identified Incorrect grounding pad placement While this pad is not an Intuitive Surgical product the proper placement of the ground pad is important for proper dispersion of return energy when using monopolar energy No contact or incomplete contact can cause the inability to deliver energy or cause patient burns at the grounding pad site respectively Moving Instrument While Out of View Articulation of instrument off screen Moving instruments while they are out of the surgeon s field of view can lead to unintended tissue damage and potentially significant patient harm depending on the tissue type at issue This can happen when a surgeon is trying to identify an instrument that has shifted off screen or when taking control of a 3 arm off screen Insertion or removal of an instrument not in view ISI P N 1012739 Rev B EU English Attachment B Page 3 of 4 Urgent Medical Device Correction 2955842 05212014 002 C Attachment B Risk to Health Appendix i Inserting instruments into the patient without using direct visualization can lead to unintended tissue damage and potentially significant patient harm depending on the tissue at issue There are two reported instances where damage of critical vessels during blind insertion of an instrument resulted in patient death Unintentional tissue damage These are instances where surgical error resulted in u
41. ded best practices for instrument installation section Instrument Installation Best Practices 1 Verify the sterile adapter discs are aligned using the process above before installing an instrument 2 Do not squeeze the release levers while installing the instrument onto the Sterile Adapter 3 Do not apply excessive force when installing the instrument 4 Verify pins on the back of the arm are flush on the arm and not protruding ISI P N 1012739 Rev B EU English Attachment C Page 33 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Troubleshooting Sequence 1 If the instrument does not engage properly reseat the instrument 2 If the problem is not resolved reseat the sterile adapter using the Sterile Adapter Engagement Verification process on page 6 11 3 If the problem is not resolved re drape the arm For assistance contact Technical Support U S 800 876 1310 International 800 0821 2010 or 41 21 821 2020 Manual Location Original Change da Vinci Si System Section 9 4 N A Added Warning Manual WARNING During an instrument exchange including using Guided Tool Change the surgeon must not remove his her hands from the masters until he she has removed his her head from the stereo viewer Manual Location Original Change INTUITIVE ISI P N 1012739 Rev B EU English Attachment C Page 34 of 48
42. des ESU use There are ESUs that offer auto fire settings In this setting the generator automatically fires when the grips of the instrument are closed If the user is unaware that they are operating in this setting energy will deliver unexpectedly when they grasp tissue with the instrument This can lead to unintended tissue damage Exceeding recommend settings EndoWrist instruments are rated for a max voltage threshold If power settings are selected that supply higher voltage than the instruments are rated for the high voltages could cause insulation break down This can create arcing from unexpected areas of the wrist leading to unintended tissue damage Disconnection power down of non user facing components The da Vinci system has multiple components that need to be powered and properly connected for the system to be used The instrument control box ICB is a part of the system that sits on the vision cart and controls the vessel sealer and stapler instruments Like the Improper Unplugged other components the ICB needs to be powered and connected in order for the rest of the System Connections system to be used but unlike the other components the main power and connection are not intended for interaction by the users If the users unintentionally disconnect power down the ICB and do not know how to reconnect the system will not be available for use This could result in aborts of da Vinci procedures Inability to rele
43. ding with another instrument with significant force both instruments can be damaged and drop fragments into the patient These fragments have different potential compositions included ceramic or Ultem pieces from the cautery instruments pieces of tungsten cable stainless steel grip tips from a variety of instruments or titanium pieces from the Harmonic instrument These pieces would have to be identified and retrieved in order to completely mitigate risk to patient Interoperative cleaning causes tip damage During a procedure tissue accumulates on the tips of all instruments especially cautery instruments If a second instrument is used to remove the debris from the instrument one or Instrument to Instrument 7 both instruments can be damaged in the same way as described above Interactions Instrument to shaft collision causes shaft damage Similar to above if collisions are made between the shaft of two instruments the shafts can be damaged and particulates can fall in the patient In the case of the 5mm instruments this can lead to skiving off a piece of the nylon coating This piece would have to be identified and retrieved in order to completely mitigate risk to patient Instrument to Tip Cover collision causes damage In the case of instrument collisions with the tip cover the tip cover can be damaged If not identified this could result in arcing through the damaged areas of the tip cover and potential unintended tissue da
44. e cannula To confirm secure attachment Ensure that the 8mm Cannula Seal and EndoWrist Stapler Cannula Seal are visibly seated around the circumference of the cannula bowl Ensure that the 5mm Cannula Seal clicks into place Ensure that all four tabs on the 8 5 13mm Seal PN 420206 are over the cannula lip ISI P N 1012739 Rev B EU English Attachment C Page 35 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 21 1 Device Description section Added sentence in Device Description section Accessories User The disposable seal consists of an The disposable seal consists of an internal valve and seal to prevent gas leakage Manual internal valve and seal to prevent gas when instruments are inserted or withdrawn The 8 mm seal includes a built in leakage when instruments are inserted 5 mm converter to prevent leakage and allow insertion of instruments of or withdrawn The 8 mm seal includes a different diameters than the main seal The seal is to be assembled with the built in 5 mm converter to prevent Intuitive cannula To use attach the disposable seal assembly securely to the leakage and allow insertion of top of the cannula Ensure that the seal is visibly seated around the instruments of different diameters than circumference of the cannula bowl Insert the obturator through the seal into the main seal The seal is to be the cannula
45. e inside or outside the field of view This damage could occur at instruments may cause tissue damage points near the tip or at the port site cannula of the energized instrument inside or outside the field of view Instruments and Section 19 2 Step 4 in Intraoperative Use Section Added and updated Step 5 formerly Step 4 in Intraoperative Use Create a skin incision using standard surgical procedure Under vision introduce the cannula and obturator assembly applying continuous controlled pressure on the obturator Make sure that the obturator tip is pointing away from anatomic structures during insertion ISI P N 1012739 Rev B EU English Attachment C Page 43 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Accessories User Manual Section 2 1 N A Added bullet Do not deliberately or unintentionally use one instrument to energize other endoscopic instruments Energizing other endoscopic instruments may cause tissue damage inside or outside the field of view This damage could occur at points near the tip or at the port site cannula of the energized instrument Instruments and Accessories User Manual Section 4 1 N A Added bullet Exercise caution when working with monopolar instruments close to other instruments Unintended energy may be delivered from the active monopolar instrument to a second instrument This could res
46. e of and full view of the very carefully and only with the Surgeon Console operator Do not remove the instrument if it is not in view knowledge of and full view of the Surgeon Console operator Vessel Sealer User Section 2 3 N A Added Warning Manual WARNING Always insert and remove the instrument under visualization da Vinci Si System Section 9 4 Instrument Removal Steps Updated Instrument Removal Steps Manual 1 Before instrument removal the Surgeon Console operator should do the following a Ensure the instrument tip is free and clear of any patient anatomy b Straighten the instrument wrist c Open the instrument jaws instrument removal is difficult with jaws closed d Clearly communicate to the Patient Cart operator which instrument to remove Identify the name of the instrument or the number of the instrument arm e g instrument arm 1 2 3 2 Once the instrument is positioned for removal the Patient Cart operator should squeeze the release levers on 1 Before instrument removal the Surgeon Console operator should do the following a Ensure that the instrument tip is in view and is free of any patient anatomy b Straighten the instrument wrist c Clearly communicate to the patient side assistant which instrument to remove Identify the name of the instrument or the number of the instrument arm e g instrument arm 1 2 3 2 Once the instrument is positioned for removal the patient side
47. efer to the ESU s manual for making this connection For Gyrus ESUs refer to Chapter 7 PK Dissecting indications and instructions in making Forceps this connection For Gyrus ESUs refer to Chapter 7 PK Dissecting Forceps Instruments and Section 3 1 N A Added Warning Accessories User WARNING The return electrode must be properly affixed to the patient Manual before the use of electrocautery to prevent patient or operator injury Single Site OUS Section 10 2 N A Added Note under Monopolar Cautery Settings section Manual Note Refer to the Instruments and Accessories User Manual PN 550675 for appropriate instrument cord connections and for proper setup instructions pertaining to use of the ERBE ICC 350 ERBE VIO 300D and Covidien Force Triad generators Single Site OUS Section 10 2 N A Added Warning Manual WARNING Patient dispersive electrode must be properly applied to the patient and plugged into the ESU prior to the use of electrocautery ISI P N 1012739 Rev B EU English Attachment C Page 40 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Single Site OUS Section 10 2 N A Added Table 10 3 Compatible Instrument Cords for Monopolar and Bipolar Manual Energy Energy Type Compatible Instrument Cord Reusable Monopolar Cord Valleylab E2999 Reusable Bipolar Cord Kirwan 10 5000 Single Site OUS Section 10 2 Step 3 section Update
48. en inserting the grip release tool opening jaws clearing jaws release levers and carefully withdraw from tissue and removing the instrument from the system the instrument Single Site OUS Section 9 2 WARNING In case of system failure Updated Warning Manual Section 13 2 while this instrument is grasping tissue WARNING In case of system failure while this instrument is grasping tissue the the jaws can be opened manually by inserting the emergency grip release or Allen wrench into the proximal hole in the instrument housing Squeeze the release levers and carefully withdraw the instrument grips can be manually opened by inserting the grip release tool into the grip release hole in the instrument housing and carefully turning Squeeze the release levers and carefully withdraw the instrument Use visualization of surgical site when inserting the grip release tool opening jaws clearing jaws from tissue and removing the instrument from the system ISI P N 1012739 Rev B EU English Attachment C Page 20 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Vessel Sealer User Section 2 3 N A Added Warning Manual WARNING Do not perform grip release on a non faulted system without first pressing the Emergency Stop button Failure to observe this warning may result in unintended instrument motion or damage to the grip release mechani
49. ent D for affected Manuals IFU s QRG s and IRK by country and language ISI P N 1012739 Rev B EU English FSCA 2955842 05212014 002 C Page 1 of 7 f N J IC l N T Y I V E Date 17 November 2014 SURGICAL O o be taken b Please take the following actions SAMs z 1 Ensure all appropriate personnel are fully informed of this Notification Forward this letter to your Risk Manager OR Director Purchasing Manager Biomedical Engineering staff and members of your medical staff who perform da Vinci surgery procedures 2 Review labeling changes and related information as outlined in Attachments A B and C Use Attachment D to identify the specific labeling that has been updated in your language 3 No user manuals or other labeling should be returned Discard old versions of the User Manuals IFUs and QRGs for which you have received updated versions 4 No products should be returned Discard all versions of the Emergency Grip Release Wrench Part Number 710142 Order additional IRKs from Intuitive Surgical as needed 5 Complete and return the attached Acknowledgement Form to acknowledge that you have received the updated Labeling IRKs in service and have discarded all previous versions of Labeling and the Emergency Grip Release Wrench Please return the completed Acknowledgment Form within two days of the in service 6 Retain a copy of this Notice and your completed Acknowledgement Form for your records LAA ahi 1 Intui
50. g end effector glowing red Instruments and Section 3 2 N A Added Warning Accessories User WARNING Ensure that Auto Start is not selected for Bipolar modes To Manual properly configure the ERBE ICC 350 ERBE VIO 300D and Covidien Force Triad for use with the surgeon console footswitch follow the instructions below Instruments and Section 3 1 N A Added Warning Accessories User WARNING Make sure the electrosurgical unit ESU or generator is properly Manual functioning before connecting it and using it with the system Instruments and Section 3 3 The EndoWrist instruments are The EndoWrist monopolar instruments are intended for electrosurgical Accessories User Manual intended for electrosurgical applications They are designed for a maximum peak voltage of 3kV in the applications They are designed for a maximum peak voltage of 3kV in the coagulate and cut settings with validated ESUs Refer to the ESU s manual ISI P N 1012739 Rev B EU English Attachment C Page 5 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes coagulate and cut settings with for maximum peak voltage specifications validated ESUs Instruments and Section 3 3 Table 3 2 Maximum ESU Power Updated content for the ConMed System 5000 ESU Accessories User Settings to Stay Below 3kV Limit Manual Instruments and Section 3 3 The corresponding
51. instrument is positioned for removal the patient side assistant of the instrument arm e g instrument should squeeze the release levers on the sides of the instrument and pull the arm 1 2 3 2 Once the instrument is positioned for removal the Patient Cart instrument out operator should squeeze the release levers on the sides of the instrument and pull the instrument out then clear the sterile adapter Manual Location Original Change INTUITIVE ISI P N 1012739 Rev B EU English Attachment C Page 31 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci Si System Section 4 2 Note The system cables have a fiber Added Take care to avoid stepping on the cable since this can damage it to Manual optic core Care should be taken to existing Note Note The system cables have a fiber optic core Care should be avoid bending the cable as kinks can taken to avoid bending the cable as kinks can damage the cable and may damage the cable and may prevent prevent system operation The minimum safe bend radius is 1 inch 2 54 cm system operation The minimum safe Take care to avoid stepping on the cable since this can damage it bend radius is 1 inch 2 54 cm Manual Location Original Change da Vinci Si System Section 6 3 N A Added Sterile Adapter Engagement Verification content below picture and Manual
52. ion 15 2 Step 6 in Intraoperative Use section Updated Step 6 in Intraoperative Use section Manual thick black ring should be placed within to thick black ring be placed within thick black ring should be placed within to thick black ring must be placed within ISI P N 1012739 Rev B EU English Attachment C Page 25 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Manual Location Original Change Instruments and Section 2 1 N A Added bullet Accessories User Use instruments with care Avoid contact between instruments Manual intraoperatively and do not use one instrument to apply force to another instrument inside the patient Instruments and Section 19 2 Visual Inspection Hold the item up Added in Visual Inspection Hold the item up close and visually inspect for Accessories User close and visually inspect for defects defects Examples of defects include rough edges dents an out of round Manual Examples of defects include shape or a bent cannula shaft Figure 19 1 below shows examples of roughedges dents or an out of round defective cannulae and a cannula that is not defective shape Figure 19 1 below shows examples of defectivecannulae and a cannula that is not defective Instruments and Section 4 2 N A Added Note Accessories User During use if the blades become contaminated by
53. ist the seal until it clicks into place For the 8 5 mm Endoscope Cannula ensure that all four tabs on the seal are over the cannula lip ISI P N 1012739 Rev B EU English Attachment C Page 37 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Single Site OUS Section 10 2 The corresponding maximum ESU Added The approved ESUs Monopolar Coag Modes and corresponding Manual power settings to stay below the 3kV maximum ESU power settings to stay below the 3kV peak limit are as follows peak limit are as follows Do not use an unlisted ESU or Monopolar Coag mode Manual Location Original Change da Vinci Si System Section 1 4 First Bullet First Bullet Manual Place the dispersive electrode as close Ensure that the dispersive electrode is securely affixed to the patient placed as possible to the operating field as close as possible to the operating field and properly connected to the ESU Instruments and Section 3 2 N A Add Caution after Table 3 2 Accessories User CAUTION Connect the ESU to the EndoWrist instrument using the Manual appropriate monopolar bipolar instrument cord Refer to the ESU s manual for indications and instructions in making this connection Monopolar cords may only be connected to monopolar receptacles and bipolar cords to bipolar receptacles Instruments and Section 3 2 N A Added Instrument Cord Connections inst
54. ively remove the instrument from the system and wipe the instrument tip with moist sterile gauze Instruments and Section 2 1 Bullet Updated bullet to replace intraoperatively to inside the patient Accessories User Do not use an instrument to clean Do not use an instrument to clean debris from another instrument inside the Manual debris from another instrument patient This may result in damage to the instruments or other unintended intraoperatively This may result in consequences such as disconnection of the instrument tip damage to the instruments or other unintended consequences such as disconnection of the instrument tip Single Site OUS Section 9 1 N A Added bullet Manual Use instruments with care Avoid contact between instruments intraoperatively and do not use one instrument to apply force to another instrument inside the patient ISI P N 1012739 Rev B EU English Attachment C Page 27 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Single Site OUS Section 11 2 N A Added Note Manual Note During use if the tip becomes contaminated by carbonized tissue remove the instrument and wipe the tip with a piece of moistened sterile gauze to remove the tissue Do not use another instrument to clean the tip Single Site OUS Section 14 2 N A Added sentence Do not push the instrument into cartilage bone or other Manual har
55. mage Low illuminator settings cause a dark image The required vision settings are different for each case The settings can be adjusted to optimize the image based on tissue working distance etc In the case where the vision Incorrect Vision Settings settings have been adjusted without the surgeon realizing it the image can be made too dim to complete the necessary surgical tasks If the settings are not adjusted it can lead to conversion of the surgery to an alternative surgical approach Failure to straighten instrument prior to instrument removal While instruments are back drivable and will straighten when pulled out of the cannula it is more abusive to the instrument to have the instrument straightened by the cannula during removal rather than the surgeon straightening the distal tip prior to removal If the instrument is not straightened and is extracted quickly and forcefully this can lead to impact Instrument Removal loads on the distal components of the instruments Some of the instruments have potential to be damaged in this scenario and could result in pieces falling in the patient especially the ceramic sleeves on the permanent cautery instruments This piece would have to be identified and retrieved in order to completely mitigate risk to patient Instrument thought to be stuck on sterile adapter release levers not depressed ISI P N 1012739 Rev B EU English Attachment B Page 2 of 4 Urgent Medical Device
56. mal release levers and withdraw the instrument Use visualization of surgical site hole in the instrument housing when inserting the grip release tool opening jaws clearing jaws from tissue Squeeze the release levers and and removing the instrument from the system carefully withdraw the instrument Single Site OUS Section 9 2 N A Added Grip Release section ISI P N 1012739 Rev B EU English Attachment C Page 19 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Manual Single Site OUS Section 13 2 N A Added Warning WARNING Do not perform grip release on a non faulted Manual system without first pressing the Emergency Stop button Failure to observe this warning may result in unintended instrument motion or damage to the grip release mechanism Single Site OUS Section 12 1 WARNING In case of system failure Updated Warning Manual while this instrument is grasping tissue WARNING In case of system failure while these instruments are grasping the jaws can be opened manually by tissue the grips can be manually opened by inserting the grip release tool into inserting the emergency grip release or the grip release hole in the instrument housing and carefully turning Squeeze Allen wrench into the proximal hole in the release levers and carefully withdraw the instrument Use visualization of the instrument housing Squeeze the surgical site wh
57. maximum ESU Updated to Accessories User power settings to stay below the 3kV The approved ESUs Monopolar Coag Modes and corresponding maximum ESU Manual limit are as follows power settings to stay below the monopolar instrument 3kV limit are as follows Do not use an unapproved ESU or unlisted monopolar coag mode Single Site OUS Section 10 2 N A Added Recommended use of monopolar Cut mode section Manual Recommended use of monopolar Cut mode 1 Any monopolar Cut mode can be used however use the lowest power setting that achieves the desired effect 2 Apply energy for the minimum time necessary to achieve the desired effect 3 Ensure that instrument tips are not glowing red and that there is not a blue plasma cloud surrounding the tips The power setting is too high if these indications are observed Single Site OUS Section 10 2 WARNING Do not exceed the 500V WARNING Do not exceed the 500V peak limit with bipolar instruments Doing Manual peak limit Doing so may result in so may result in electrical arcs and alternate site burns See Table 10 5 for electrical arcs and alternate site burns maximum ESU power settings to stay below this limit Do not use any generator or mode not listed ISI P N 1012739 Rev B EU English Attachment C Page 6 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Single Site OUS Secti
58. mum ESU Power Settings to Manual ESU Power Settings to Stay Below 3kV Peak Stay Below 3kV Peak Limit for approved ESUs and Monopolar Coag modes ISI P N 1012739 Rev B EU English Attachment C Page 7 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Single Site OUS Section 10 2 Table 10 5 Title Table 10 5 Maximum Table 10 5 Added to end of title Table 10 5 Maximum ESU Power Settings to Manual ESU Power Settings to Stay Below 500V Stay Below 500V Peak Limit for Approved ESUs and Bipolar Modes Peak Limit Single Site OUS Section 10 2 The Single Site Instruments are Updated to be specific for Monopolar instruments Manual intended for electrosurgical The Single Site monopolar Instruments are intended for electrosurgical applications They are designed for a applications They are designed for a maximum peak voltage of 3kV in the maximum peak voltage of 3kV in the coagulate and cut settings with validated ESUs Refer to the ESU s manual coagulate and cut settings with for maximum peak voltage specifications validated ESUs Refer to the ESU s manual for maximum peak voltage specifications Single Site OUS Section 10 2 WARNING Do not exceed the 3kV peak Updated Warning to be specific for Monopolar instruments Manual limit Doing so may result in electrical WARNING Do not exceed the 3kV peak limit
59. n cause unintended instrument motion or damage to the grip release mechanism da Vinci Si System Section 12 2 N A Added Instrument Release Kit section Manual Clean and sterilize the instrument release kit in the same way as the grip release tool For grip release tool cleaning and sterilization instructions refer to the Reprocessing Instructions PN 550875 ISI P N 1012739 Rev B EU English Attachment C Page 17 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci Si System Section 9 4 N A Updated Grip Release Warnings instructions and terminology including Manual removal of Emergency from Grip Release heading Updated Steps to clarify to always use visualization to rotate approximately 1 4th turn to carefully turn the tool to support the instrument arm before clutching and not to reuse the instrument after grip release Instruments and Section 2 1 N A Added Warning Accessories User Section 5 1 e Do not perform grip release on a non faulted system without first pressing Manual Section 6 1 the Emergency Stop button Failure to observe this warning may result in Section 7 1 unintended instrument motion or damage to the grip release mechanism Section 8 1 Section 9 1 Section 11 1 Instruments and Section 8 1 WARNING In case of system failure Updated Warning Accessories User Section 9 1 while this instrument is grasping tissue In c
60. nd Country Japanese Japan 550660 05_A 551068 03_ A NA 550972 04_A 551284 06_A 551989 01_A 552645 01 NA 552900 01 552901 01 552902 01 550970 03_A 551102 02_A 381269 01 Korean South Korea 550661 06_ A 551069 03 A NA 550686 05 A 551285 06_A 552613 01_A 552646 01 NA 552698 01 552724 01 552750 01 550529 03_A 551103 02_A 381270 01 Norwegian Norway 550663 06_A 551071 04_A NA 550688 05_A 551287 06_A 552615 01_A 552648 01 552674 01 552700 01 552726 01 552752 01 550531 03_A 551105 02_A 381272 01 Polish Poland 550671 05_A 551072 04 A NA 550580 04_A 551288 06_A 552616 01_A 552649 01 NA 552701 01 552727 01 552753 01 NA 551106 02_A 381273 01 Portugal Portuguese Brazil 550664 06_A 551073 04_A NA 550689 05_A 551289 06_A 552617 01_A 552650 01 NA 552702 01 552728 01 552754 01 550535 03_A 551107 02_A 381274 01 Romanian Romania 550665 06_A 551074 04 A NA 550690 05 A 551290 06_A 552618 01_A 552651 01 NA 552703 01 552729 01 552755 01 550532 02_ A 551108 02_A 381275 01 Russian Russia 550666 05 A 551075 04 A NA 550691 04 A NA NA 552652 01 NA 552704 01 552730 01 552756 01 550533 03_A 551109 02_A 381253 01 Slovakian Slovak Republic 551391 03_A 551394 03 A NA 551392 03_A 551399 04_A 552622 01_A 552654 01 NA 552706 01 552732 01 552758 01 NA 551526 02_A 381277 01 Slovenian Slovenia 550428 05_ A 551076 04_ A NA 550637 04_A 551293 06_A 552621 01_A 55265
61. nintended tissue damage If unable to be repaired such damage can lead to serious injury or death There are two reported instances of patient death due unintentional tissue damage Surgical Error Unrelated to Cannula insertion causing damage System Use Cannula insertions are common to all minimally invasive surgery and are completed prior to the introduction of the da Vinci system to the procedure The camera cannula is not a device provided by Intuitive Surgical This cannula is sometimes introduced without direct visualization There are two reported instances where incorrect camera cannula insertion resulted in patient death ISI P N 1012739 Rev B EU English Attachment B Page 4 of 4 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Table of Contents Improper Electrosurgical ESU Use Improper Unplugged System Connections Procedure for Converting While Instrument is Grasping Tissue Unintended Use of Instruments Improper Installation of Tip Accessory Instrument to Instrument Interactions Incorrect Vision Settings Instrument Removal Damaged Cables Installation and Use of Sterile Adapters and Drapes User Releases Master Tool Manipulator MTM s While Head in High Resolution Stereo Viewer HRSV 3rd Party Equipment Improper ESU Connections Moving Instrument While Out of View Surgical Error Unrelated to System Use ISI P N 1012739 Rev B EU
62. nt motion or damage to the grip release mechanism da Vinci S System Section 8 4 N A Added Warning Manual WARNING Do not perform grip release on a non faulted system without first pressing the Emergency Stop button Failure to observe this warning may result in unintended instrument motion or damage to the grip release mechanism ISI P N 1012739 Rev B EU English Attachment C Page 12 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes da Vinci Si System Manual Section A 2 Emergency Stop Press the red Emergency Stop button on the right side pod of the Surgeon Console should it be necessary to stop system operation at any time When you press Emergency Stop the system classifies it as a recoverable fault which you can override by pressing Recover on the touchpad or touchscreen Changed Emergency Stop content Emergency Stop Press the red Emergency Stop button should it be necessary to stop system operation at any time The Emergency Stop button will cease robotic control of the instruments and endoscope The instruments and endoscope will stay in their last commanded position If the instrument grips are closed when the Emergency Stop button is pressed the grips will remain closed However the gripping force of the instrument may decrease Pressing Emergency Stop initiates a recoverable fault which you can override
63. on 10 2 Monopolar Cautery Settings Added sentences under Monopolar Cautery Settings Manual Set the ESU to the desired monopolar Set the ESU to the desired monopolar output Keep the monopolar coag output Set the power as low as settings below the maximum settings in Table 10 4 below Set the power as possible to achieve adequate low as possible to achieve adequate hemostasis Any monopolar Cut mode can hemostasis be used however follow the Recommended use of monopolar Cut mode Single Site OUS Section 10 2 N A Added Warning Manual WARNING Ensure that the ESU is properly functioning prior to connecting and using with the system Single Site OUS Section 10 2 The corresponding maximum ESU Added Manual power settings to stay below the 500V The approved ESUS Bipolar Coag Modes and corresponding maximum ESU peak limit are as follows power settings to stay below the 500V peak limit are as follows Do not use an unlisted ESU or mode Single Site OUS Section 10 2 The corresponding maximum ESU Added Manual power settings to stay below the 3kV The approved ESUs Monopolar Coag Modes and corresponding maximum ESU peak limit are as follows power settings to stay below the 3kV peak limit are as follows Do not use an unlisted ESU or Monopolar Coag mode Single Site OUS Section 10 2 N A Updated all settings in table 10 4 Manual Single Site OUS Section 10 2 Table 10 4 Title Table 10 4 Maximum Table 10 4 Added to end of title Table 10 4 Maxi
64. onsole control to release the the system from the patient 1 Remove instrument grips the instruments and endoscope from a In case of system failure while the instrument is grasping tissue the grips the patient 2 Disconnect the cannulae can be manually opened by following the grip release instructions see Grip from the instrument and camera Release on page 9 13 Chapter 9 Patient Cart Use arms 3 Move the instrument and WARNING Do not perform grip release on a non faulted system without first camera arms away from the patient pressing the Emergency Stop button Failure to observe this warning may a result in unintended instrument motion or damage to the grip release Note If the system is in an error state mechanism while converting to open surgery the WARNING Rotating the grip release tool too far and or in the incorrect Patient Cart will still allow use of the direction can cause unintended instrument motion or damage to the grip port clutch buttons If the system loses release mechanism all power the arms and setup joints 2 Disconnect the cannulae from the instrument and camera arms may be overpowered to move the arms 3 Move the instrument and camera arms away from the patient aenecessary Note If the system is in a fault state while converting to open surgery the Patient Cart will still allow use of the port clutch buttons If the system loses all power the arms and setup joints may be overpowered to move the arms as nece
65. ootswitch Do not select either of the Auto Start modes When selected the circle next to the soft button is filled green as shown ISI P N 1012739 Rev B EU English Attachment C Page 4 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 3 3 WARNING Do not exceed the 3kV peak Added to Warning Accessories User limit Doing so may result in electrical WARNING Do not exceed the 3kV peak limit with monopolar instruments Manual arcs and alternate site burns Doing so may result in electrical arcs and alternate site burns See Table 3 3 for maximum ESU power settings to stay below this limit for monopolar Coag mode Do not use any generator or monopolar Coag mode not listed in this table Instruments and Section 3 3 WARNING Excessive power levels may Added to Warning Accessories User result in instrument malfunction and WARNING Excessive power levels may result in instrument malfunction and Manual possible patient or user injury Reduce possible patient or user injury Reduce power setting if any of the following power setting if any of the following effects are observed excessive arcing excessive tissue charring excessive effects are observed excessive arcing overheating of end effector e g end effector glowing red or emitting a blue excessive tissue charring excessive plasma cloud overheating of end effector e
66. ot be applied to an instrument when it is not in direct contact with tissue referred to as air firing Additionally do not use an electrosurgical instrument to apply cautery to any other instrument e Be aware of critical anatomy in contact with the instrument during energy activation While activating monopolar energy be aware of anatomy that is in contact with the instrument wrist or shaft The instrument should not be used as a retractor while applying energy e Survey the surgical field During each procedure surgeons should survey the surgical field particularly where the distal end of the instrument shaft may have been in contact with tissue Survey tissue surrounding the main surgical field including areas below or behind the cannula and endoscope that are normally outside the field of view e Consider patient condition Before using monopolar cautery in a procedure consider factors that may make a patient s anatomy and tissue more susceptible to injury from the application of cautery for example patients that have received radiation therapy prior to surgery Additional changes for section 5 1 only e The Instrument must always be used in conjunction with the appropriately sized Intuitive Surgical 8 mm metal cannula e The Instrument should never be used with an Intuitive Surgical 8 mm metal cannula inserted through a plastic cannula ISI P N 1012739 Rev B EU English Attachment C Page 45 of
67. p release tool opening jaws clearing jaws from tissue Squeeze the release levers and and removing the instrument from the system carefully withdraw the instrument Instruments and Section 6 1 WARNING In case of system failure Updated Warning Accessories User Section 7 1 while the instrument is grasping tissue WARNING In case of system failure while these instruments are grasping Manual the grip jaw can be opened manually tissue the grips can be manually opened by inserting the grip release tool into by inserting the emergency grip release the grip release hole in the instrument housing and carefully turning Squeeze or an Allen wrench into the proximal the release levers and withdraw the instrument Use visualization of surgical hole in the instrument housing site when inserting the grip release tool opening jaws clearing jaws from Squeeze the release levers and tissue and removing the instrument from the system carefully withdraw the instrument Instruments and Section 11 1 WARNING In case of system failure Updated Warning Accessories User while the instrument is grasping tissue WARNING In case of system failure while this instrument is grasping tissue the Manual the grip jaw can be opened manually grips can be manually opened by inserting the grip release tool into the grip by inserting the emergency grip release release hole in the instrument housing and carefully turning Squeeze the or an Allen wrench into the proxi
68. ra Control Unit and Illuminator is correctly set to the on of its component power switches for position indicated by I on the switch These components are not intended the Core Camera Control Unit and to be turned off or disconnected at any time unless you are directed to do so Illuminator is correctly set to the on by Intuitive Surgical Product Support Also confirm that each Vision Cart position indicated by I on the component power cord is plugged into the integrated Vision Cart power strip switch Also confirm that each Vision Cart component power cord is plugged into the integrated Vision Cart power strip Vessel Sealer User Section 1 6 Note Do not turn off the rear power Updated Note Manual switch on the ICB unless directed to do Note Do not turn off the rear power switch or disconnect any cables on the so by Intuitive Surgical Product ICB unless directed to do so by Intuitive Surgical Product Support Support ICB Instrument Control Box Manual Location Original Change da Vinci S System Section 8 4 N A Added Grip Release Warning Manual WARNING Do not perform grip release on a non faulted system without first pressing the Emergency Stop button Failure to observe this warning may result in unintended instrument motion or damage to the grip release mechanism UITIVI ISI P N 1012739 Rev B EU English Attachment C Page 10 of 48 Urgent Medical Device Correction 29
69. ructions and Table 3 2 Compatible Accessories User Instrument Cords for Monopolar and Bipolar Energy Manual Energy Type Manufacturer Compatible Instrument Cord Valleylab Monopolar 800 722 8772 Reusable Monopolar Cord Valleylab E2999 www valleylab com Kirwan Surgical Products Bipolar 888 547 9267 Reusable Bipolar Cord Kirwan 10 5000 www ksp com Instruments and Section 3 2 N A Added ITUITIVE ISI P N 1012739 Rev B EU English Attachment C Page 38 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Accessories User Image of the Megadyne generator in Figure 3 10 Instrument Cord Connections Manual Instruments and Section 3 3 N A Added Note Accessories User Note Ensure that the monopolar instrument cord is plugged into the Manual monopolar receptacle on the ESU and that the bipolar instrument cord is plugged into the bipolar receptacle on the ESU Instruments and Section 3 3 N A Added Note Accessories User Note The Covidien Force FX C has multiple monopolar outputs In this case Manual there are two receptacles on the front for the monopolar instrument cord and two outlets on the back for the energy activation cable Ensure that the monopolar instrument cord is plugged into the receptacle corresponding to the outlet that the energy activation cable is plugged into Instruments and Section 7 2 Step
70. rument jaws by turning the thumbwheel in the direction of the arrow to release the tissue Once the tissue is released close the jaws In this case it is OK to close the jaws on an exposed blade Squeeze the release levers and carefully withdraw the instrument Vessel Sealer User Section 2 3 N A For additional information regarding the Emergency Stop button see the da Manual Vinci Si System User Manual PN 550650 Vessel Sealer User Section 2 3 N A Added Perform these steps while visualizing the surgical site Manual Accessories User Manual 1 Before inserting a scalpel instrument into an instrument arm cannula slide the blade protector on to the Manual Location Original Change Instruments and Section 13 2 N A Added image for Figure 13 3 Snap fit Blade installed incorrectly and content Accessories User Manual Instruments and Section 13 2 Step 3 in Insertion Tool section Added sentence to Step 3 in Insertion Tool section Accessories User 3 Insert the scalpel blade into the wrist 3 There should be no gap between the accessory tip base and the instrument Manual until it is firmly seated as shown see Figure 13 4 for improperly seated Snap Fit Blade Instruments and Section 13 2 Step 1 in Blade Protector section Updated Step 1 in Blade Protector section 1 Before inserting a scalpel instrument into an instrument arm cannula slide the wider end of the blade protector on to the inst
71. rument shaft until the scalpel blade is completely covered by the sleeve of the blade protector Figure ISI P N 1012739 Rev B EU English Attachment C Page 22 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes instrument shaft until the scalpel blade is completely covered Figure 13 4 13 5 Manual Instruments and Section 13 1 N A Added Warning Accessories User Warning The Snap fit Scalpel instrument used in combination with the Snap Manual fit 15 Blue Blade or Snap Fit Paddle Blade disposable accessory tips should not be used to cut or incise large organs or tissue If used in this manner the accessory tip may be damaged and fall into the patient Single Site OUS Section 14 2 N A Added sentence Do not push the instrument into cartilage bone or other Manual hard objects in Intraoperative Use section Vessel Sealer User Section 1 5 N A Added Warning WARNING Do not use the Vessel Sealer on bone or other hard surfaces Manual Location Original Change Instruments and Accessories User Manual Section 17 2 N A Added in Instrument and Laser Use section If the instrument is removed and re installed loosen the Touhy Borst adapters withdraw the sheath and fiber into the instrument tip and re tighten the Touhy Borst adapters prior to re installing and inserting the instrument
72. sia 800 0821 2020 or 41 21 821 2020 8 am to 6 pm CET or email ics intusurg com ISI P N 1012739 Rev B EU English FSCA 2955842 05212014 002 C Page 3 of 7 Date 17 November 2014 URGICAL INTUITIVE Urgent Medical Device Correction 2955842 05212014 002 C Attachment A In Service Checklist Instrument Release Kit In Service Checklist da Vinci Standard da Vinci S da Vinci Si da Vinci Si e The Instrument Release Kit consists of a wrench and instruction tag The instruction tag has different in Wrench structions on Side 1 and Side 2 Carefully read each step to familiarize yourself with the process of manual grip release For a complete list of Instruction Tag manual grip release warn Side 1 Side 2 ings and cautions refer to the system user manual Pressing Emergency Stop ensures the system is properly faulted to suc cessfully perform manual grip release The direction of wrench rotation is unique for each instrument Turning the wrong direction may cause unintended instru ment motion or damage to the grip release mech anism United States United States 800 876 1310 800 876 1310 International international 800 0821 2020 or 4121 821 2020 Instrument Release Kit inci do Vind Standard Si Si e ISI P N 1012739 Rev B EU English FSCA 2955842 05212014 002 C Page 4 of 7 N U L Date 17 November 2014 Urgent Medical Device Correction 2955842 05212014 002 C Att
73. sired fiber Manual 11 Tighten the proximal and sliding position is reached Verify that the fiber and sheath are properly secured Touhy Borst adapters when desired Gently pull back on the sheath exiting the instrument housing and confirm no fiber position is reached movement of the sheath occurs Gently pull back on the fiber exiting the sheath No motion of the fiber should occur Instruments and Section 19 2 Step 3 in Intraoperative Use Added to Step 3 in Intraoperative Use Accessories User Manual 3 Insert the obturator fully into the cannula 3 Insert the obturator fully into the cannula If using a latching obturator ensure that the latches are fastened over the rim of the cannula If using a non latching obturator ensure that the obturator is seated firmly against the seal and that the tip of the obturator appears at the distal end of the cannula sleeve ISI P N 1012739 Rev B EU English Attachment C Page 24 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 17 2 Step 8 in Assembly Instructions Added to Step 8 in Assembly Instructions section 8 Slide the sliding Touhy Accessories User section Borst adapter along the sheath and twist lock the luer connector onto the Manual 8 Slide the sliding Touhy Borst adapter female luer at the back of the instrument Tighten the Touhy Borst adapter
74. sm Vessel Sealer User Section 2 3 N A Added Grip Release instructions Manual Basis for instruction is from the 1S3000 System user manual content with new instruction on how to use the thumbwheel for grip release which is specific to the Vessel Sealer instrument Vessel Sealer User Section 2 3 N A Added Grip Release Note Manual Note The EndoWrist instrument release kit PN 381199 includes a grip release tool attached to illustrated instructions for quick reference Be sure to keep a sterile instrument release kit in an accessible location Vessel Sealer User Section 2 3 N A Added Grip Release Note Manual Note Whenever possible use Surgeon Console control to release the instrument grips Vessel Sealer User Section 2 3 N A Added Warning Manual WARNING After removal of the instrument during a system or instrument failure use caution when opening the jaws using the thumbwheel to avoid potential injury due to an exposed cutting blade Vessel Sealer User Section 2 3 N A Added Warning Manual WARNING Do not use the grip release tool on the Vessel Sealer instrument ISI P N 1012739 Rev B EU English Attachment C Page 21 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Vessel Sealer User Section 2 3 N A Added Warning Manual WARNING In case of system failure while the instrument is grasping tissue open the inst
75. ssary da Vinci Si System Section 9 4 N A Added Grip Release Note Note The EndoWrist instrument release kit PN Manual 381199 includes a grip release tool attached to illustrated instructions for quick reference Be sure to keep a sterile instrument release kit in an accessible location da Vinci Si System Section 9 4 N A Added Grip Release Note Manual Section A 3 Note Whenever possible use Surgeon Console control to release the ISI P N 1012739 Rev B EU English Attachment C Page 16 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes instrument grips da Vinci Si System Section 9 4 N A Added Grip Release Warning Manual Section A 3 WARNING Do not perform grip release on a non faulted system without first pressing the Emergency Stop button Failure to observe this warning may result in unintended instrument motion or damage to the grip release mechanism da Vinci Si System Section 9 4 N A Added Grip Release Warning Manual WARNING Do not reuse an instrument that has had its grip released with the instrument release kit Reusing an instrument after use of the instrument release kit could result in critical failure of the instrument and injury to the patient da Vinci Si System Section 9 4 N A Added Grip Release Warning Manual Section A 3 WARNING Rotating the grip release wrench too far and or in the incorrect direction ca
76. t in burns to tissue in contact with any of the Vessel Sealer s metal parts or its cannula To exercise caution in these scenarios the monopolar tip should be closer to the tissue than to the Vessel Sealer ISI P N 1012739 Rev B EU English Attachment C Page 48 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment D Affected Manuals IFU s QRG s and IRK by Language and Country Language Country IS3000 User Manual Single Site User Manual Stapler 45 l A User Manual Addendum I amp A User Manual Vessel Sealer User Manual Vessel Sealer QRG Grip Release QRG Grip Release Addendum 1S1200 ESU Setting QRG Core Connection QRG NRL QRG 1S2000 User Manual Trouble shooting Flow Charts IRK with Vessel Sealer US English United States 550650 07_A 551184 06_E 550986 06_D 550675 06_G 551027 07_F 551182 05_D 551979 05 551980 02 551992 02 551993 02 551997 01 5505 16 06_C 550866 03_B 381199 01 EU English Canada Great Britain Ireland Israel Qatar Lebanon Pakistan Kuwait South Africa India Singapore Thailand Malaysia Philippines Indonesia Australia New Zealand Saudi Arabia Egypt Iceland Hong Kong 550650 07_A 550965 09_A NA 550675 06_G 551027 07_F 551182 05_D 551979 05 551980 02 551992 02 551993 02 551997 01 5505 16 06_C 550866 0
77. tive Surgical representatives will be available by phone to answer questions related to BAS this Urgent Medical Device Correction 2 An Intuitive Surgical Representative will perform an in service relating to the information in Attachment A of this Notice and will be available to answer any questions you may have ormation amp If you need further information or support concerning this Notice please contact your Intuitive PRS Surgical Representative or Intuitive Surgical Customer Service at the numbers listed below e North America and South America 800 876 1310 Option 3 6 am to 5 pm PST e Japan 0120 56 5635 or 03 5575 1362 9 am to 6 pm JST e South Korea 02 3271 3200 9 am to 6 pm KSTJ e Europe Middle East India Asia and Africa 800 0821 2020 or 41 21 821 2020 8 am to 6 pm or ics intusurg com Please be informed that the appropriate Regulatory Authority for your region has been notified of this notification Sincerely Intuitive Surgical ISI P N 1012739 Rev B EU English FSCA 2955842 05212014 002 C Page 2 of 7 Date 17 November 2014 Field Safety Notice Urgent Medical Device Correction 2955842 05212014 002 C Labeling Update for da Vinci Standard S and Si Surgical Systems Instruments and Accessories Hospital Name lt mail merge field gt Address lt mail merge field gt City State Zip lt mail merge field gt System Number lt mail merge field gt NSID lt mail merge field gt ATTEN
78. tive motion If the engagement issue cannot be resolved abort or conversion of the surgery may be necessary User Releases Master Tool Manipulator MTM s While Head in High Resolution Stereo Viewer HRSV Releasing masters with head in console The surgical masters are balanced to minimize surgeon fatigue during use However if the surgeon releases the masters but keeps his her head in the console the masters do not lock in position and can float unintentionally If the balance of the masters is off the masters can move and the instruments will follow This unintended motion of the instruments can lead to unintended tissue damage 3rd Party Equipment Using wrong ESU connection to the system In most ORs there are multiple ESUs and connections If the wrong connector is used to connect an ESU into the system the control of the ESU can be incorrect This can lead to firing of the wrong energy mode and potentially cause unintended tissue damage While many connectors are not able to be connected to an incorrect ESU that is not compatible this safety feature is not available for all ESUs and connector cables Improper ESU Connections Connection into proper receptacle Most ElectroSurgical Units ESUs have a monopolar and a bipolar receptacle If an instrument is connected to the incorrect receptacle when activated the energy would be delivered to the incorrect instrument This could result in energy delivery to unintende
79. uld be closer to the tissue than to the second instrument Instruments and Section 19 1 Bullet in CAUTION To minimize the Removed When possible from bullet in CAUTION To minimize the risks Accessories User risks associated with port placement associated with port placement ensure the following Manual ensure the following Visualization of the entire insertion of the cannula using an endoscope is When possible visualization of the preferred entire insertion of the cannula using the endoscope is preferred ISI P N 1012739 Rev B EU English Attachment C Page 46 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Single Site OUS Manual Section 7 N A Added A Ensure that the patient is positioned to shift organs away from the port placement site and that an adequate level of insufflation has been achieved before introducing the cannulae under For patient safety during insertion of Single Site curved cannulae Single Site OUS Manual Section 15 2 N A Added Caution CAUTION Ensure that the remote centers of all cannulae are within the boundaries of the Single Site port Failure to position the remote centers appropriately may generate excessive forces on the patient body wall damage the port or cannulae or result in loss of insufflation Single Site OUS Manual Section 11 1 N A Added Warning
80. ult in burns to tissue in contact with any of the second instrument s metal parts or its cannula To exercise caution in these scenarios the monopolar tip should be closer to the tissue than to the second instrument Instruments and Accessories User Manual Section 19 2 N A Added new Step 4 in Intraoperative Use Before introducing the cannula ensure that the patient is positioned to shift organs away from the port placement site and that an adequate level of insufflation has been achieved Instruments and Accessories User Manual Section 4 1 Bullet Added to bullet Be aware of critical anatomy in contact Be aware of critical anatomy in contact with the instrument during energy with the instrument during energy activation While activating monopolar energy be aware of anatomy that is in activation While activating monopolar contact with the instrument wrist or shaft The instrument should not be used energy be aware of anatomy thatisin as a retractor while applying energy contact with the instrument wrist or shaft ISI P N 1012739 Rev B EU English Attachment C Page 44 of 48 Urgent Medical Device Correction 2955842 05212014 002 C Attachment C Identification of Labeling Changes Instruments and Section 5 1 N A Added under General Precautions and Warnings Accessories User Manual Section 16 1 e Do not apply energy when the instrument tip is not in contact with tissue Energy should n

Urgent Medical Device Correction – 2955842

Contents

Download Pdf Manuals

Related Search

Related Contents

Urgent Medical Device Correction &ndash; 2955842

Contents

Download Pdf Manuals

Related Search

Related Contents

Urgent Medical Device Correction – 2955842