To users of the V5Ms transesophageal transducer #32800000
Contents
1. SXY 10 L0 169 Z9Z971L 11 CEL SIEMENS CUSTOMER SAFETY ADVISORY NOTIFICATION To users of the V5Ms transesophageal transducer 32800000 42300000 Dear Valued Customer This letter is to notify you of an issue with the V5Ms transesophageal transducer When does this issue arise and what is the potential risk We have received recent reports about the deterioration of material covering the articulating section of the V5Ms transesophageal transducer Although to date no patient injury has been reported a compromise or fault in this material combined with a failure to use a probe cover as directed in the user manual may cause esophageal cuts bleeding and perforation to the patient and severe trauma electrical burns and serious electrical hazards to the patient and the user However a leakage current test can indicate cracks cuts tears perforations and protrusions in the articulation material The potential risk is avoided only if you perform the recommended leakage current test of the transesophageal transducer prior to each use What steps can the user take to avoid potential risk of this issue To avoid the potential risk associated with this issue the following steps are required a Perform the leakage current test for a transesophageal transducer prior to each use Follow the manufacturer s instructions included with the tester Use only Siemens approved cleaning and disinfecting solutions Carefully follow the manufa2. 685 East Middlefield Road Tel 650 969 9112 Ultrasound Business Unit Mountain View CA 94043 Tel 800 422 8766 1 1 PN 11146767
3. cturer s instructions Siemens recommends that you use market cleared transducer sheaths specifically designed for TEE applications Follow the instructions provided by the manufacturer of the transducer sheath a When you store the transesophageal transducer take extreme care that the distal tip is straight Never move the distal tip by hand Always use the flex controls The recommended steps are provided in the existing user manual for your ultrasound system How will this issue be resolved If you notice any damage or wear on your transducer or if the transducer fails to pass the leakage current test immediately discontinue use of the transducer and contact your local Customer Service Engineer If you have any questions please contact your local service support person for information regarding timelines and status Please share this information with all personnel within your organization who need to be aware of this issue As always patient safety issues are a high priority and we alert customers of product concerns which may occur under various conditions This problem was discovered as part of our ongoing quality process We sincerely regret any inconvenience this condition may cause in your daily operations Sincerely jj A A ALN WZ ia Sheila Pickering Ph D A Senior Director Quality and Regulatory Affairs Siemens Medical Solutions USA Inc Ultrasound Business Unit English Siemens Medical Solutions USA Inc
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