PKG, METZENBAUM SCISSORS, CURVED LONG

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE BROKE AND POTENTIALLY REMAINED IN THE PATIENT.

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.

Additional Manufacturer Narrative

THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: DEVICE BREAKING AND POTENTIALLY REMAINING IN THE PATIENT PROBABLE ROOT CAUSE: USE ERROR MANUFACTURING/ SERVICING ERRORS THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE BROKE AND POTENTIALLY REMAINED IN THE PATIENT.