SINGLE FUNCTION HANDPIECE ABC PENCIL

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 130344, SINGLE FUNCTION ABC PENCIL, 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 UPON REOCCURRENCE.

Additional Manufacturer Narrative

RECEIVED ONE 130344 IN UNOPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION OF THE DEVICE, THERE IS AN OPEN HOLE IN THE SEAL. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED, WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. 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. A 2 YEAR LOT HISTORY REVIEW WAS CONDUCTED PER CSP1187813 REV D AND FOUND THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; THESE DEVICES SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF DAMAGE IS FOUND: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS; BROKEN OR SIGNIFICANTLY BENT HANDLE, SHAFT OR CONNECTOR CONTACTS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.