PKG, 5MM MULTI-FUNCTION PEEK HANDLE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS BURNED. IT WAS CONFIRMED THAT IT WAS MINOR AND DID NOT NEED MEDICAL INTERVENTION.

Additional Manufacturer Narrative

ALLEGED FAILURE: THIS CUSTOMER EXPERIENCED AN ELECTRICAL ARCHING ON A LAP INSTRUMENT THAT BURNED THE PATIENT. THE INFORMATION ON THE EQUIPMENT IS BELOW. THEY WOULD LIKE AN ASSESSMENT DONE ON BOTH PIECES TO UNDERSTAND HOW IT HAPPENED. THEY ARE NOT INTERESTED IN REPAIRING/REPLACING THESE ITEMS AT THIS TIME. HOW CAN WE SET THIS UP? SALESFORCE CASE NUMBER (B)(4). THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE/S COULD BE THIRD PARTY REPAIR AND/OR MULTIPLE USAGE INCLUDING STERILIZATION CAUSING THE INSULATION TO DEGRADE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS BURNED. IT WAS CONFIRMED THAT IT WAS MINOR AND DID NOT NEED MEDICAL INTERVENTION.