CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE

Description of Event or Problem

IN PREPARATION FOR AN UNKNOWN PROCEDURE, THE USER SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THEY NOTICED THAT THE JAWS [FORCEPS CUPS] CAME OFF AND TWO WIRES WERE PRESENT ON THE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

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 CLEAR 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. DURING A VISUAL EXAMINATION, IT WAS NOTED THAT THE ENTIRE CUP ASSEMBLY AND HOUSING WAS BROKEN AND DETACHED FROM THE SHEATH. BOTH LINK WIRES APPEAR TO BE BROKEN. WHEN THE HANDLE IS MANIPULATED, THE DRIVE WIRE ADVANCES AS EXPECTED. UNDER MAGNIFICATION, IT APPEARED THAT THERE WAS WELD MARKS PRESENT ON THE INSIDE OF THE HOUSING BUT WERE LESS EVIDENT ON THE SHEATH. THE DEVICE WAS NOT TESTED IN THE ENDOSCOPE DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS RETURNED TO THE SUPPLIER FOR FURTHER EVALUATION AND THE FOLLOWING WAS PROVIDED, "VISUAL EVALUATION OF THE RETURNED DEVICE CONFIRMED THE COMPLAINT OF WIRE NOT ATTACHED TO THE JAWS. NO DAMAGE WAS VISIBLE TO THE REST OF THE JAW ASSEMBLY, COIL CABLE, COATING OR HANDLE COMPONENTS OF THE DEVICE. DUE TO THE CONDITION OF THE RETURNED DEVICE, FULL FUNCTIONALITY OF THE DEVICE COULD NOT BE PERFORMED. THE COMPLAINT OF WIRE DETACHED FROM THE JAWS WAS CONFIRMED WITH VISUAL EVALUATION. THE DEVICE COMPONENTS WERE DISASSEMBLED AND REMOVED FROM THE DEVICE. DEVICE COMPONENTS SHOWED NO INTERNAL SIGNS OF DAMAGE. WHEN THE TIP ASSEMBLY WAS DISASSEMBLED, IT WAS OBSERVED THAT THE LASER WELD LOCATION WAS NOT PROPERLY PLACED. THE TIP ASSEMBLY WAS DETACHED FROM THE CABLE WHICH MAY HAVE RESULTED IN SNAPPING OF THE FORMED DRIVE WIRES. THE PTS FOR THE FORMED DRIVE WIRE WAS REVIEWED AND NO DEFECTS WERE NOTED, DEEMING THAT FORMED DRIVE WIRE IS NOT THE ROOT CAUSE. THE JAW ASSEMBLY SHOWED NO DEFECTS. THE ROOT CAUSE OF DETACHMENT OF CUPS FROM THE CABLE AND SNAPPING OF THE WIRE HAS BEEN DETERMINED TO BE BOTH METHOD AND HUMAN ERROR. ALTHOUGH PROCEDURES REQUIRE THE OPERATORS TO CHECK FOR A QUALITY WELD, IT DOES NOT INSTRUCT THE OPERATORS TO VERIFY THE WELD USING A REFERENCE. AS A RESULT OF THIS RMA, DOCUMENTATION WILL BE UPDATED TO REFLECT VISUAL A STANDARD AND THE PROCESS TRAVELER (PT) WILL BE UPDATED TO INCLUDE A VISUAL INSPECTION SIGN OFF FOR LASER WELD. REQUIRED TRAINING WILL ALSO BE COMPLETED AS A PART OF THIS UPDATE." THE DEVICE HISTORY RECORDS WERE REVIEWED AND WERE MANUFACTURED APRIL 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 EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE SUPPLIER PROVIDED THE FOLLOWING, "ROOT CAUSE WAS DETERMINED TO BE AN IMPROPERLY PLACED WELD, DUE TO INSUFFICIENT INSTRUCTION IN THE PROCESS TRAVELER AND HUMAN ERROR. BOTH PROCEDURES FOR LASER WELD AND THE ASSOCIATED PROCESS TRAVELER WILL BE REVISED TO INCLUDE A VISUAL STANDARD. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ANOMALIES. A VISUAL EVALUATION OF THE RETURNED DEVICE CONFIRMED THE CUSTOMER'S COMPLAINT. A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. FURTHER EVALUATION OF THE DEVICE REVEALED THE ROOT CAUSE TO BE THE WELD WAS NOT PROPERLY PLACED." 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: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.