CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE

Additional Manufacturer Narrative

CONTINUED: INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR BIOHAZARD BAG. NO LOT NUMBER WAS RETURNED WITH THE DEVICE. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH THE CUPS BENT TO ONE SIDE. THE CUPS WOULD OPEN AS EXPECTED; HOWEVER, THE CUPS WOULD NOT FULLY STRAIGHTEN WHEN THE HANDLE WAS IN THE CLOSED POSITION AND THE CUPS WOULD NOT FULLY CLOSE. THE CUPS WERE NOT MISALIGNED, THEY MESHED TOGETHER AS EXPECTED. THE DEVICE WAS NOT TESTED IN THE ENDOSCOPE DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS SENT TO THE SUPPLIER FOR FURTHER EVALUATION AND THE FOLLOWING WAS PROVIDED, "THE VISUAL INSPECTION OF THE CAPTURA PRO DEVICE REVEALED THAT THE FORKS WERE NOT FULLY CLOSED DURING THE WELDING PROCESS. WHEN OPENING AND CLOSING THE DEVICE THE PROXIMAL END OF THE NEEDLE SOMETIMES SLIPS OUT BETWEEN THE FORK HALVES CAUSING THE TIP TO BECOME MISALIGNED. DUE TO THE CONDITION OF THE DEVICE, IT WAS NOT FUNCTIONALLY TESTED USING A SCOPE. HOWEVER, THE CUPS DO OPEN AND CLOSE AND ARE NOT MISALIGNED. THE NEEDLE WAS NOT PROPERLY POSITIONED BETWEEN THE FORK HALVES DURING THE WELDING PROCESS. THE NEEDLE CAN MOVE BETWEEN ONE SIDE OF THE FORK HALVES. ALL CAPTURA PRO DEVICES ARE 100% INSPECTED PER MANUFACTURING INSTRUCTIONS TO VERIFY THERE ARE NO GAPS BETWEEN THE MATING SURFACES OF THE FORKS." THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE A DHR REVIEW WAS NOT PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE SUPPLIER PROVIDED THE FOLLOWING, "ROOT CAUSE WAS DETERMINED TO BE HUMAN ERROR. AWARENESS TRAINING AND RETRAINING WILL BE PERFORMED FOR BOTH OPERATORS AND FQC INSPECTORS. AS THE LOT NUMBER WAS NOT PROVIDED A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. A VISUAL/ FUNCTIONAL EVALUATION OF THE DEVICE CONFIRMED THE CUSTOMER'S COMPLAINT. IN ADDITION TO AWARENESS TRAINING, OPERATORS WILL BE RETRAINED ON PROCEDURES AND FQC INSPECTORS WILL BE RETRAINED ON FQC CHECKLIST CAPTURA PRO FORCEPS. PRIOR TO DISTRIBUTION, ALL CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPORT IS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

Additional Manufacturer Narrative

THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

Description of Event or Problem

DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE FORCEPS CUPS APPEAR MALFUNCTIONED; HANGING LOOSE, BUT NOT FULLY DETACHED FROM THE DEVICE. IT APPEARS THE DRIVE WIRE MAY HAVE BROKEN ON THE DISTAL END. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. IT WAS CONFIRMED BY THE CUSTOMER THAT NO ADDITIONAL INFORMATION WILL BE PROVIDED. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.