CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE

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 A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE TIP OF THE FORCEPS BROKE OFF AFTER PUT INTO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE BUT HAD TO CUT THE FORCEPS OFF TO REMOVE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. THE PHOTO PROVIDED SHOWS AN ENDOSCOPIC IMAGE OF THE DISTAL DEVICE COMPONENTS, AND THE CUPS ARE STILL ATTACHED TO THE DEVICE, BUT BENT. THE HOUSING IS NOT VISIBLE IN THE PHOTO. 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 WERE CUT FROM THE SHEATH, AND NOT INCLUDED IN THE RETURN. WHEN THE HANDLE IS MANIPULATED, THE DRIVE WIRE ADVANCES SLIGHTLY. UNDER MAGNIFICATION, IT DID NOT APPEAR THAT THERE WERE WELD MARKS PRESENT 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 DEVICE CONFIRMS THE COMPLAINT. THE WELD MARKS ARE NOT AT THE DESIRED LOCATION CAUSING THE TIP ASSEMBLY TO PULL OUT. THERE WERE NO DEFECTS ON THE DISMANTLED HANDLE. THE INTERNAL COMPONENTS OF THE HANDLE SHOWED NO DAMAGE. FUNCTIONAL EVALUATION OF THE RETURNED DEVICE COULD NOT BE PERFORMED AS THE TIP ASSEMBLY WAS NOT INCLUDED IN THE RETURNED DEVICE. THE VISUAL EVALUATION CONFIRMED THE COMPLAINT, AS THE DEVICE WAS RETURNED WITHOUT THE TIP ASSEMBLY, THE FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION REVEALED THAT THE WELD WAS AT IMPROPER LOCATION. THE CABLE WAS CHECKED FOR IMPROPER TRIM COATING, IT PASSED THE TEST AS PER TRIM COATING INSTRUCTIONS AND VISUAL STANDARDS PROPER JACKET TRIMMING. THE WELD LOCATION ON THE TIP ASSEMBLY COULD NOT BE DETERMINED AS IT WAS NOT INCLUDED IN THE RETURNED DEVICE. THE CABLE PASSED ALL THE REQUIRED TESTS, THE ROOT CAUSE OF THE IMPROPER WELD IS DETERMINED TO BE METHOD AND HUMAN ERROR. PROCEDURES HAVE BEEN UPDATED TO CLEARLY INSTRUCT THE OPERATORS TO VISUALLY CHECK THE WELD LOCATION DURING BOTH ASSEMBLY. THE DEVICE HISTORY RECORD WAS REVIEWED AND WAS MANUFACTURED OCTOBER 2024. THERE WERE NO RELEVANT DEFECTS NOTED IN THE MANUFACTURING/FQC CHECKLIST. 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, "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 RETURNED DEVICE. FURTHER EVALUATION OF THE DEVICE REVEALED THE ROOT CAUSE TO BE THE WELD WAS NOT PROPERLY PLACED. ROOT CAUSE WAS DETERMINED TO BE IMPROPERLY PLACED WELD, DUE TO INSUFFICIENT INSTRUCTION IN THE PROCEDURE AND PROCESS TRAVELER AND HUMAN ERROR. BOTH PROCEDURE AND THE ASSOCIATED PROCESS TRAVELER ARE BEING REVISED TO INCLUDE VISUAL STANDARDS. AWARENESS TRAINING ON THE PROPER WELDING LOCATION AND INSPECTION WAS PERFORMED ON 12/10/2024. 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: SUPPLEMENTAL REPORT IS BEING SUBMITTED TO LINK UF REPORT 5201770000-2024-8300 MDR REPORT KEY (B)(4) TO OUR MANUFACTURER REPORT NUMBER 1037905-2024-00847.

Description of Event or Problem

DURING A COLONOSCOPY PROCEDURE IN THE CECUM, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE TIP OF THE FORCEPS BROKE OFF AFTER PUT INTO THE SCOPE. THE DOCTOR WAS UNABLE TO REMOVE THE DEVICE AND HAD TO PULL OUT THE SCOPE WITH THE FORCEPS STICKING OUT THE END OF THE SCOPE. THE REGISTERED NURSE IN THE ROOM TOOK A WIRE CUTTER AND CLIPPED THE END OF THE DEVICE SO IT COULD BE REMOVED FROM THE SCOPE. THIS ADDED TIME TO THE PROCEDURE AND ANESTHESIA WAS LOST. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE BUT HAD TO CUT THE FORCEPS OFF TO REMOVE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.