552180-01 Rev B Customer Letter Single Site Grip
Contents
1. INTUITIVE 14 September 2015 SURGICAL Field Safety Notice Urgent Medical Device Correction 2955842 08 08 15 008 C da Vinci Si Single Site Grip Release Dear da Vinci Customer The purpose of this Field Safety Notification is to advise you of an issue that could potentially occur involving specific da Vinci Si Single Site gripping instruments Under rare circumstances grip actuated instruments may become fixed in a closed position A list of affected instruments can be found in the Affected Regions and Products section of this letter Roll gear End Effector Figure 1 Single Site gripping instrument example This potential failure has been attributed to excessive force exerted on the instrument during insertion into a curved cannula which may result in 1 A break in the roll gear and or instrument shaft 2 Damage to the push pull mechanism that controls grip opening and closing This potential breakage where the shaft meets the roll gear can occur when excessive force is applied during instrument insertion through the curved cannula The potential break can be in the roll gear only the shaft only or both and can vary from a hairline crack to a complete break between the components The nature of the failure mode is such that it may worsen with continued use the grips may open and close normally following the initial insertion and Field Action unexpectedly remain closed later in the case even when using the instr2. SE FAX OR EMAIL THIS ACKNOWLEDGEMENT FORM TO Intuitive Surgical Inc ATTN REGULATORY COMPLIANCE Subject line for email da Vinci Si Single Site Grip Release lt Insert Regional Contact Information gt Customer Service North America and South America 800 876 1310 Option 3 6 AM to 5 PM PST South Korea 02 3271 3200 9 AM to 6 PM KSTJ Europe Middle East Asia and Africa 800 0821 2020 or 41 21 821 2020 8 AM to 6 PM CET or ics intusurg com PN 552180 01 Rev B 2955842 08 08 15 008 C Page 4 of 6 INTUITIVE SURGICAL Attachment 1 Instructions to Manually Open da Vinci Si Single Site Grasping Instrument Grips 14 September 2015 If the grips cannot be opened from the masters at the Surgeon Console or by using the instrument release kit due to damage to the shaft and or roll gear the grips can be opened manually To manually open the grips 1 Verify that the Emergency Stop button was pressed and the system is still in a faulted state 2 Verify that the grip release tool is in place in the housing and carefully turn the tool counterclockwise approximately 1 4th turn until it engages and can no longer turn Keep the tool engaged during the following steps Figure 1 Figure 1 Keep the grip release tool engaged while manually opening the grips 3 Under visualization have the patient side assistant grasp the instrument shaft below the break Figure 2A and manually pull the shaft back toward the instrument housi
3. further information or support concerning this issue please contact your Clinical Sales Representative or contact ntuitive Surgical Customer Service at the numbers listed below e North and South America 800 876 1310 Option 3 6 AM to 5 PM PST or mail customersupport servicesupport intusurg com Further Information amp Support Europe Middle East Asia and Africa 800 0821 2020 or 41 21 821 2020 8 AM to 6 PM CET or ics intusurg com South Korea 02 3271 3200 9 AM to 6 PM KSTJ Please be informed that the appropriate Regulatory Authority for your region has been notified Sincerely Intuitive Surgical S rl Chemin des M riers 1 1170 Aubonne Switzerland 41 21 821 2020 PN 552180 01 Rev B 2955842 08 08 15 008 C Page 3 of 6 14 September 2015 ACKNOWLEDGEMENT FORM Field Safety Notice Urgent Medical Device Correction 2955842 08 08 15 008 C da Vinci Si Single Site Grip Release Hospital Name lt mail merge gt Address lt mail merge gt City Postal Code lt mail merge gt NSID lt mail merge gt ATTENTION lt mail merge gt 1 Ihave received and read this notice 2 Ihave ensured all appropriate personnel are fully informed of the contents of this notice 3 will contact Intuitive Surgical if have any questions Name print Position Snae C Robotics Coordinator __ Operating Room Director C Risk Manager Hospital Name C Surgeon C Other Phone Number Email Date PLEA
4. instruments have been identified to contain the push pull mechanism All lots relating to the following part numbers could potentially exhibit this failure Part Numbers Product Name and Versions 428050 12 428050 13 Maryland Dissector 428050 14 PN 552180 01 Rev B 2955842 08 08 15 008 C Page 2 of 6 14 September 2015 Please Take the Following Actions 1 Ensure that all affected personnel are fully informed of this notice Forward this notice to your Risk Manager OR Director Purchasing Manager Biomedical Engineering staff and members of your medical staff who perform da Vinci Si Surgery procedures Actions to be Replace any instrument that shows signs of damage and contact Intuitive Surgical taken by the Customer Service Customer If you encounter an issue where the instrument grips remain closed on tissue and the User IRK cannot be used please follow the instructions on Attachment 1 Complete and return the attached Acknowledgment Form to ntuitive Surgical using the instructions provided Please retain a copy of this notice as well as the attached instructions with your da Vinci Si Single Site User Manual Intuitive Surgical will update documentation via an addendum to the user manual and complete Actions GN an analysis of the product design taken by Intuitive Surgical Intuitive Surgical representatives will be available by phone to answer any questions related to this Medical Device Correction If you need
5. ng Figure 2B to reduce the gap between the broken components Figure 20 CAUTION Tissue or objects may move as the grips are released Roll Gear Figure 2 A Grasp the instrument shaft below the break B Pullthe shaft toward the housing C Reduce the gap between separated component PN 552180 01 Rev B 2955842 08 08 15 008 C Page 5 of 6 lt Date place holder gt e Ifthe black outer shaft covering or other components inside the housing are blocking the shaft from being pulled back toward the housing a slight twisting motion of the roll gear the tan color piece may help to move the obstruction Figure 3 Roll Gear Figure 3 Twist the roll gear tan color piece while holding the shaft in place Note Twisting the roll gear should only be performed under endoscopic view as the instrument grips may also twist e If the space between the cannula and the instrument is not enough to hold the instrument firmly with the fingers use forceps or other available surgical tool to aid the process and repeat Step 3 CAUTION Tissue or objects may move as the grips are released 4 Under visualization clear the tissue from the grips If needed adjust the instrument arm to position the instrument away from the tissue Support the instrument arm before clutching to prevent unintended instrument motion 5 After the tissue is cleared from the grips squeeze the release levers on the sides of the instrument housing and pull the ins
6. trument out Do not reuse the instrument 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 After manually opening the instrument grips either with the instrument release kit or by following the steps above return the affected instrument to ntuitive Surgical by contacting Customer Service PN 552180 01 Rev B 2955842 08 08 15 008 C Page 6 of 6
7. ument release kit IRK See Figure 2 for example of the instrument roll gear and shaft break Introduction and Reason for Figure 2 Examples of breaks at the roll gear and instrument shaft junction PN 552180 01 Rev B 2955842 08 08 15 008 C Page 1of6 INTUITIVE SURGICAL Risk to Health Affected Regions and Products 14 September 2015 In the worst case scenario in which a da Vinci Si Single Site instrument grip cannot be released normally or by opening the masters or using the instrument release kit the surgeon may need to excise tissue in order to extract the gripped instrument To mitigate this risk instructions on how to open the grips have been provided in Attachment 1 There has been one reported instance out of 81 413 distinct procedures 0 001 related to da Vinci Si Single Site instrument grips becoming fixed in the closed position while gripping tissue The da Vinci Si Single Site User manual provides guidelines for how to properly handle the da Vinci Si Single Site instruments The instruments will work as intended if users continue to adhere to these guidelines Affected Countries Australia Belgium Brazil Canada Chile China Cyprus Denmark France Germany Greece Israel Italy Monaco Netherlands Panama Romania Saudi Arabia Singapore South Korea Spain Sweden Switzerland Taiwan Turkey United Kingdom and United States Affected Product The following da Vinci Si Single Site
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