THE BROKEN 530 IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. PHOTOGRAPHIC EVIDENCE WAS PROVIDED BUT THE REPORTED FAILURE COULD NOT BE VERIFIED. THIS COMPLAINT OF BROKEN DEVICE IS UNABLE TO BE VERIFIED AND A ROOT CAUSE CANNOT BE DETERMINED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 1 COMPLAINTS, REGARDING 1 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). IT IS STANDARD MEDICAL PRACTICE TO INSPECT MEDICAL EQUIPMENT PRIOR TO USE.
D
Patient 1
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 530., REFLEX ELC, 20M/L CLIPS, 10/11MM, DEVICE MADE AN AUDIBLE SOUND WHILE BEING USED BY THE SURGEON DURING A PROCEDURE ON (B)(6) 2018. THE CASING TO THE DEVICE SPLIT OPEN AND THEN A SMALL PIECE OF PLASTIC WAS SEEN BY THE TEAM ON THE PATIENT'S LIVER. THE SURGEON REMOVED THE PLASTIC PIECE FROM THE PATIENT. THIS EVENT CAUSED A 10-MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS NORMAL USING AN ALTERNATE DEVICE. THERE WAS NO MEDICAL INTERVENTION OR EXTENDED HOSPITAL STAY FOR THE PATIENT DUE TO THIS EVENT. THERE WAS NO REPORT OF INJURY TO THE USER OR THE PATIENT FOR THIS EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.