SINGLE FUNCTION HAND PIECE ABC ELECTRODE

Additional Manufacturer Narrative

RECEIVED ONE 130344 IN OPENED UNORIGINAL PACKAGING. LOT NUMBER WAS NOT VERIFIED. PERFORMED A VISUAL INSPECTION, THE NOZZLE TIP OF THE HAND PIECE WAS MELTED. THE NEEDLE HAD OBVIOUS SIGNS OF SUSTAINING HIGH TEMPERATURES. THE PROXIMAL END OF THE CABLE CORD WHERE IT IS CONNECTED INTO THE UNIT WAS MELTED AS WELL. ONCE HAND PIECE WAS OPENED THE CABLE WAS INSPECTED, WHERE THE CABLE CONNECTS TO THE CONNECTION RIBBON, THERE WAS EVIDENCE OF EXPOSED WIRING THAT OVERHANG THE DISTAL END OF THE RIBBON. A 2-YEAR LOT HISTORY COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD COULD NOT BE REVIEWED SINCE NO LOT NUMBER WAS PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 4 COMPLAINTS REGARDING 4 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE (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.

Additional Manufacturer Narrative

THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED AND IS AWAITING AN 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) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 130344, SINGLE FUNCTION ABC PENCIL'S TIP MELTED AND THE BODY OF THE HAND PIECE WAS HOT DURING A PROCEDURE WHILE TRYING TO CREATE HEMOSTASIS ON THE BREASTBONE ON (B)(6) 2019. THE TYPE OF PROCEDURE IS UNKNOWN. THE SETTINGS USED WERE 80WATTS AND 100WATTS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME ABC PENCIL. THE WAS NO REPORTED DELAY. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.