ABC

Additional Manufacturer Narrative

NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. A DEVICE HISTORY RECORD (DHR) REVIEW FOUND A NON-CONFORMANCE; HOWEVER, IT WAS NOT RELATED TO THE MANUFACTURE OF THE PRODUCT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 9 COMPLAINTS, REGARDING 9 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT CARE SHOULD BE TAKEN DURING SURGERY TO PREVENT CONTACT OF THE PENCIL TIP WITH TISSUE TO ENSURE PROPER ABC® EFFECT. THESE DEVICES SHOULD BE INSPECTED BEFORE USE AND DISCARDED IF DAMAGED. VISUALLY EXAMINE THE DEVICES FOR THE FOLLOWING: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS. DAMAGE INCLUDING CUTS, PUNCTURES, NICKS, ABRASIONS, UNUSUAL LUMPS, AND SIGNIFICANT DISCOLORATION. VERIFY THAT THE ELECTRODE IS FULLY SEATED IN THE HANDPIECE BEFORE USE. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem

THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 13021, ABC HANDPIECE TRIPLE OPTION HANDPIECE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6)2025 WHEN IT WAS REPORTED, ¿DURING A ROUTINE SURGERY IN THE OPERATING ROOM, MODEL 130321 WAS USED. AFTER THE PROCEDURE, IT WAS DISCOVERED THAT A SMALL SECTION OF THE NEEDLE INSIDE THE NOZZLE WAS MISSING. DESPITE THOROUGH SEARCHES IN THE OPERATING ROOM AND WITHIN THE PATIENT'S BODY, THE MISSING SECTION COULD NOT BE LOCATED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONS WERE ASKED OF THE REPORTER; UNFORTUNATELY, CONMED WAS ADVISED THAT THE HOSPITAL IS BEING RELOCATED AT THIS TIME, AND IT IS NOT POSSIBLE TO CONTACT THE RELEVANT PEOPLE AT THE HOSPITAL WHO WOULD HAVE FURTHER INFORMATION. ALSO, TWO LOT NUMBERS WERE REPORTED AND IT IS UNKNOWN IF BOTH DEVICES WERE BROKEN OR IF ONLY ONE WAS BROKEN AND WHICH ONE. LOT NUMBERS 202409114 AND 202408084. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE FOREIGN BODY LEFT IN PATIENT.

Additional Manufacturer Narrative

THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem

THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 130321, ABC HANDPIECE TRIPLE OPTION HANDPIECE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DURING A ROUTINE SURGERY IN THE OPERATING ROOM, MODEL 130321 WAS USED. AFTER THE PROCEDURE, IT WAS DISCOVERED THAT A SMALL SECTION OF THE NEEDLE INSIDE THE NOZZLE WAS MISSING. DESPITE THOROUGH SEARCHES IN THE OPERATING ROOM AND WITHIN THE PATIENT'S BODY, THE MISSING SECTION COULD NOT BE LOCATED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONS WERE ASKED OF THE REPORTER; UNFORTUNATELY, CONMED WAS ADVISED THAT THE HOSPITAL IS BEING RELOCATED AT THIS TIME, AND IT IS NOT POSSIBLE TO CONTACT THE RELEVANT PEOPLE AT THE HOSPITAL WHO WOULD HAVE FURTHER INFORMATION. ALSO, TWO LOT NUMBERS WERE REPORTED AND IT IS UNKNOWN IF BOTH DEVICES WERE BROKEN OR IF ONLY ONE WAS BROKEN AND WHICH ONE. LOT NUMBERS 202409114 AND 202408084. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE FOREIGN BODY LEFT IN PATIENT.