SINGLE FUNCTION HANDPIECE ABC ELECTRODE

Additional Manufacturer Narrative

THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE DISTRIBUTOR IN (B)(4) REJECTED ONE (1) 130344, SINGLE FUNCTION HANDPIECE ELECTRODE, DUE TO AN "INSUFFICIENT HEAT SEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INCOMING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.

Additional Manufacturer Narrative

ONE 130344 WAS RECEIVED IN UNOPENED ORIGINAL PACKAGING THE REPORTED CATALOG AND LOT NUMBERS WERE VERIFIED. VISUAL INSPECTION WAS UNABLE TO FIND ANY ABNORMALITIES OR DEFECTS. DYE LEAK TESTING OF THE DEVICE PACKAGING WAS UNABLE TO FIND A BREACH OF THE STERILE BARRIER. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; THESE DEVICES SHOULD BE INSPECTED BEFORE EACH USE. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF DAMAGE IS FOUND: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.