PKG, 5MM PEEK MONOPOLAR HANDLE

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: ARCING PROBABLE ROOT CAUSE: POOR AUTOCLAVE RELIABILITY CONTACT FORCES USE ERROR INSULATION DAMAGE OR INADEQUATE INSULATION FROM MANUFACTURING/ SERVICING THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS ARCING.

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 DEVICE WAS ARCING.