CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE

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 WOULD NOT OPEN AND CLOSE AS USUAL." OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. 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.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A BIOHAZARD BAG WITH AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH NO DAMAGE TO THE SHEATH OR HANDLE AND THE CUPS PARTIALLY CLOSED. DURING A FUNCTIONAL TEST, THE CUPS WOULD OPEN AND CLOSE WITH SOME RESISTANCE, HOWEVER THEY WOULD NOT CLOSE FULLY. ADDITIONALLY, THERE WAS A LOUD CLICKING NOISE PRESENT WHEN THE CUPS WERE OPENED FULLY. UNDER MAGNIFICATION, IT COULD BE SEEN THAT THE FORCEPS CUPS ARE PARTIALLY STUCK OPEN. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION, AND THE FOLLOWING WAS PROVIDED, "VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED NO AESTHETIC DEFECTS. NO DAMAGE WAS VISIBLE TO THE JAW ASSEMBLY, COIL CABLE, COATING, OR HANDLE COMPONENTS OF THE DEVICE. THE DEVICE WAS EVALUATED FOR FUNCTIONALITY IN THE U-BEND AND 3-COIL POSITIONS. WHILE THE CUPS OPENED EASILY IN U-BEND POSITION, IT DID NOT OPEN AND CLOSE FULLY IN 3-COIL POSITION. THE DEVICE COMPONENTS WERE DISASSEMBLED AND REMOVED FROM THE DEVICE. DEVICE COMPONENTS SHOWED NO INTERNAL SIGNS OF DAMAGE. THERE WERE NO VISUAL DEFECTS BUT THE FUNCTIONAL EVALUATION CONFIRMED THE DEFECT. WHEN CHECKED UNDER MAGNIFICATION, THE TIP WELD, FORMED WIRES, CUPS, PIVOT PIN, OR THE NEEDLE SHOWED NO VISIBLE DEFECTS OR BURRS. THE SWAGE DIAMETER OF THE TIP WAS ALSO MEASURED UNDER MAGNIFICATION AND IT MET THE REQUIREMENT. THE FORMED LINK WIRES WERE REMOVED FROM THE DISASSEMBLED TIP AND EXAMINED. BOTH THE WIRES FAIL TO MEET THE SPECIFICATIONS. ROOT CAUSE FOR THE LINK WIRES FAILING TO MEET SPECIFICATION IS UNKNOWN." THE DEVICE HISTORY RECORD WAS REVIEWED AND WAS MANUFACTURED MARCH 2024. THERE WERE NO RELEVANT DEFECTS NOTED IN THE MANUFACTURING/FQC CHECKLISTS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE RETURNED DEVICE CONFIRMED THE COMPLAINT. THE SUPPLIER PROVIDED THE FOLLOWING, "A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ANOMALIES. A VISUAL EVALUATION OF THE DEVICE DID NOT FIND ANY DAMAGE TO THE DEVICE. THE FUNCTIONAL EVALUATION OF THE DEVICE CONFIRMED THE CUPS WERE DIFFICULT TO OPEN AND CLOSE. FURTHER EVALUATION OF THE DEVICE FOUND THE LINK WIRES DID NOT MEET ALL SPECIFIED CRITERIA, THE ROOT CAUSE IS UNKNOWN." THE INSTRUCTIONS FOR USE PRODUCT INSPECTION: "BEGINNING AT THE HANDLE AND MOVING TOWARD THE CUPS, UNCOIL THE FORCEPS MAKING SURE NOT TO STRETCH THE CABLE. OPEN AND CLOSE THE CUPS TO VERIFY SMOOTH HANDLE OPERATION AND APPROPRIATE CUP ACTION. NOTE: EXERCISING THE HANDLE WHILE THE FORCEPS IS COILED MAY RESULT IN DAMAGE TO THE PERFORMANCE CHARACTERISTICS OF THE FORCEPS." PRIOR TO DISTRIBUTION, ALL CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.