BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA SERRATED LARGE FORCEP-SPIKE

    MDR report key: 6306933 · Received February 7, 2017

    Report

    Report Number
    1037905-2017-00045
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 10, 2017
    Report Date
    March 9, 2017
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCL
    UDI-DI
    00827002560765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. THE USER PROVIDED A PHOTO OF THE DEVICE WHEN THE DEVICE WAS IN THE ENDOSCOPE, THERE IS NOT ENOUGH EVIDENCE TO CONCLUSIVELY DETERMINE MISALIGNMENT BASED ON THE PHOTO. DURING OUR EVALUATION THE CUPS WERE VISUALLY EVALUATED AND POTENTIAL CUP MISALIGNMENT WAS NOT OBSERVED. THE DEVICE IS BEING SENT BACK TO THE SUPPLIER FOR FURTHER EVALUATION WHERE THE FINAL DETERMINATION OF CUP MISALIGNMENT WILL BE DETERMINED BASED ON THE MANUFACTURER¿S SPECIFICATIONS. A FUNCTIONAL TEST WAS PERFORMED AND THE FORCEPS OPEN AND CLOSED AS INTENDED. THE SUPPLIER PROVIDED THE FOLLOWING INFORMATION: ONE DEVICE FROM THE REPORTED EVENT WAS RETURNED WITH PROOF OF DECONTAMINATION. THE DEVICE WAS INSPECTED FOR MISALIGNED CUPS. UNDER MAGNIFICATION, THE VISIBLE MATERIAL THICKNESS WAS MEASURED WHICH IS GREATER THAN THE ALLOWED THICKNESS. THE DEVICE WAS INSERTED THROUGH THE TORTUOUS PATH SCOPE AND THE DEVICE OPENED AND CLOSED AS INTENDED. WHEN OPENED AND CLOSED MULTIPLE TIMES, THE DEVICE CUPS MISALIGNED INTERMITTENTLY. THE DISTANCE BETWEEN FORK ARMS WERE MEASURED IN TWO PLACES AND WERE NOT PARALLEL; HOWEVER THEY ARE WITHIN THE SPECIFIED DIMENSION. ONE LINK WIRE IS SLIGHTLY STRADDLING THE NEEDLE. THIS LINK WIRE POSITION CONTRIBUTES TO THE MISALIGNED CUP CONDITION. UNDER MAGNIFICATION, THE CUPS DO NOT APPEAR BENT OR DAMAGED IN ANYWAY. THE DEVICE HISTORY RECORDS FOR PACKAGING WORK ORDER WERE REVIEWED. THE PWO CONSISTED OF ONE ASSEMBLY ORDER. THIS AO WAS MANUFACTURED IN NOVEMBER 2016. ALL DEVICES ARE INSPECTED DURING FINAL QUALITY CONTROL (FQC) INSPECTION FOR MISALIGNED CUPS PRIOR TO RELEASE. NO RELEVANT DEFECTS WERE NOTED IN THE RECORDS. 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: THE CUSTOMER EXPERIENCED ISSUES OF "CUPS ON BIOPSY WERE MISALIGNED" WAS CONFIRMED; WHEN THE DEVICE WAS OPENED AND CLOSED MULTIPLE TIMES THE DEVICE CUPS WOULD INTERMITTENTLY MISALIGN. THE ROOT CAUSE OF THE MISALIGNMENT WAS DETERMINED TO BE DUE TO THE ONE LINK WAS SLIGHTLY STRADDLING THE NEEDLE (SPIKE) [ONE LINK WIRE WAS BENT]. ALL DEVICES ARE INSPECTED DURING FINAL QUALITY CONTROL (FQC) INSPECTION FOR PROPER OPENING AND CLOSING AS WELL AS MISALIGNED CUPS PRIOR TO PRODUCT RELEASE. THE EVALUATION COULD NOT DETERMINE WHEN THE LINK WIRE BECAME DAMAGED CONTRIBUTING TO THE MISALIGNED CUPS. NO CORRECTIVE ACTION WILL BE IMPLEMENTED AT THIS TIME. INSTRUCTIONS FOR USE STATES: "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. BECOME FAMILIAR WITH THE AMOUNT OF HANDLE MOVEMENT REQUIRED TO OPERATE THE CUPS. IF ANY IRREGULARITIES ARE NOTED, DO NOT USE. 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 SERRATED LARGE FORCEPS-SPIKE ARE SUBJECTED TO A VISUAL INSPECTION 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 ACTIONS: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. THE USER PROVIDED A PHOTO OF THE DEVICE WHEN THE DEVICE WAS IN THE ENDOSCOPE, THERE IS NOT ENOUGH EVIDENCE TO CONCLUSIVELY DETERMINE MISALIGNMENT BASED ON THE PHOTO. DURING OUR EVALUATION THE CUPS WERE VISUALLY EVALUATED AND POTENTIAL CUP MISALIGNMENT WAS NOT OBSERVED. THE DEVICE IS BEING SENT BACK TO THE SUPPLIER FOR FURTHER EVALUATION WHERE THE FINAL DETERMINATION OF CUP MISALIGNMENT WILL BE DETERMINED BASED ON THE MANUFACTURER¿S SPECIFICATIONS. A FUNCTIONAL TEST WAS PERFORMED AND THE FORCEPS OPEN AND CLOSED AS INTENDED. 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: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. INSTRUCTIONS FOR USE STATES: "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. BECOME FAMILIAR WITH THE AMOUNT OF HANDLE MOVEMENT REQUIRED TO OPERATE THE CUPS. IF ANY IRREGULARITIES ARE NOTED, DO NOT USE. 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 SERRATED LARGE FORCEPS-SPIKE ARE SUBJECTED TO A VISUAL INSPECTION 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 REMOTE. 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.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEPS-SPIKE. PRIOR TO TAKING BIOPSIES, THE PHYSICIAN NOTED THE CUPS ON THE BIOPSY FORCEPS WERE MISALIGNED AND C/O [COMPLAINS OF] DIFFICULTY TAKING SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90872 CAPTURA SERRATED LARGE FORCEP-SPIKE FCL, FORCEPS, BIOPSY, NON-ELECTRIC FCL COOK ENDOSCOPY 00827002560765

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIF 190 HD ENDOSCOPE