PKG, ENDO METZENBAUM SCISSORS, CURVED

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). *UPDATE: MINOR SEVERITY THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED, THE PROBABLE ROOT CAUSE COULD BE THIRD PARTY REPAIR. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS BURNED.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS BURNED.