ABC

Additional Manufacturer Narrative

EXAMINATION OF RETURNED USED ITEM FOUND THAT PART OF THE NOZZLE WAS MISSING. THIS CONFIRMS THE COMPLAINT THAT THE PROBE FELL OFF. THE BROKEN PIECE WAS NOT RETURNED FOR EXAMINATION. EXAMINATION WAS DONE PER PRINT 61-7182-002. A LIKELY CAUSE OF THIS ISSUE IS THE USE OF EXCESSIVE FORCE DURING INSERTION OF INSTRUMENTS. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 7 COMPLAINTS, REGARDING 7 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 0.00004. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT USE OF THE HANDPIECE WITHOUT GAS FLOW MAY CAUSE SEVERE TIP DAMAGE. MAKE CERTAIN THE ABC CONNECTOR IS FULLY SEATED INTO THE GAS SUPPLY RECEPTACLE AND MAKE SURE THE GAS SUPPLY HOSE DOES NOT BECOME KINKED OR CRIMPED. ALWAYS TEST FOR GAS FLOW PRIOR TO SURGICAL USE BY ACTIVATING THE HANDPIECE AND DIRECTING THE ACTIVE TIP TOWARD POOLED FLUID. APPROPRIATE GAS FLOW WILL RESULT IN FLUID DISPERSION PRIOR TO ESTABLISHMENT OF ARGON BEAM. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE DEVICE, 130344, ABC HANDPIECE SINGLE FUNCTION HANDPIECE, WAS BEING USED DURING A WHIPPLE PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE TIP OF THE ABC PROBE FELL OFF INTO THE PATIENT. THE TIP OF THE ABC PROBE FELL OFF INTO THE PATIENT, THE PATIENT WAS X-RAYED TO SEE IF THEY COULD LOCATE THE MISSING TIP.¿ FURTHER ASSESSMENT FOUND THAT DURING THE PROCEDURE IT WAS NOTICED THAT THE TIP OF THE DEVICE WAS PARTIALLY MISSING. IT IS BELIEVED THAT THE DEVICE WAS BROKEN DURING THE PROCEDURE. THE PENCIL WAS REMOVED FROM THE FIELD AND REPLACED WITH ANOTHER PENCIL. THERE WAS A SEARCH FOR THE MISSING TIP. AN X-RAY WAS SCHEDULED DUE TO THE TYPE OF PROCEDURE PERFORMED; HOWEVER, THE PATIENT CHART NOTATES THAT THE TIP WAS NOT FOUND. THERE WAS NO REPORT OF MEDICAL INTERVENTION. IT IS UNKNOWN IF THERE WAS EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FOREIGN BODY POSSIBLY LEFT IN PATIENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE DEVICE, 130344, ABC HANDPIECE SINGLE FUNCTION HANDPIECE, WAS BEING USED DURING A WHIPPLE PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE TIP OF THE ABC PROBE FELL OFF INTO THE PATIENT. THE TIP OF THE ABC PROBE FELL OFF INTO THE PATIENT, THE PATIENT WAS X-RAYED TO SEE IF THEY COULD LOCATE THE MISSING TIP.¿ FURTHER ASSESSMENT FOUND THAT DURING THE PROCEDURE IT WAS NOTICED THAT THE TIP OF THE DEVICE WAS PARTIALLY MISSING. IT IS BELIEVED THAT THE DEVICE WAS BROKEN DURING THE PROCEDURE. THE PENCIL WAS REMOVED FROM THE FIELD AND REPLACED WITH ANOTHER PENCIL. THERE WAS A SEARCH FOR THE MISSING TIP. AN X-RAY WAS SCHEDULED DUE TO THE TYPE OF PROCEDURE PERFORMED; HOWEVER, THE PATIENT CHART NOTATES THAT THE TIP WAS NOT FOUND. THERE WAS NO REPORT OF MEDICAL INTERVENTION. IT IS UNKNOWN IF THERE WAS EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FOREIGN BODY POSSIBLY LEFT IN PATIENT.

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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.