BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURA HOT BIOPSY FORCEPS

    MDR report key: 6182882 · Received December 16, 2016

    Report

    Report Number
    1037905-2016-00502
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    October 18, 2016
    Report Date
    January 10, 2017
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KGE
    UDI-DI
    00827002315839
    PMA / PMN Number
    K923470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EMDR REPORT WAS INITIALLY SENT ON 12/16/2016, BASED ON THE OBSERVATION THAT THE FORCEP CUPS WERE POTENTIALLY MISALIGNED. THE DEVICE WAS SENT BACK TO THE SUPPLIER FOR FURTHER EVALUATION WHERE IT WAS DETERMINED THAT THE CUPS WERE NOT MISALIGNED. THE SUPPLIER PROVIDED THE FOLLOWING INFORMATION: "ONE DEVICE FROM THE REPORTED EVENT WAS RETURNED IN A ZIP TYPE BAG WITH PROOF OF DECONTAMINATION. THE EVALUATION REVEALED THAT THE DEVICE CUPS ARE NOT MISALIGNED. THE VISIBLE CUP WALL THICKNESS IS LESS THAN THE MAX ALLOWABLE. THE DEVICE WAS OPENED AND CLOSED MULTIPLE TIMES TO CONFIRM PROPER CUP ALIGNMENT. WHEN PUT THROUGH THE TORTUOUS PATH SCOPE, THE CUPS REMAINED ALIGNED. THE DEVICE LINK WIRES WERE PROPERLY POSITIONED AS DETERMINED UNDER MAGNIFICATION. DEVICE WAS EVALUATED FOR CONTINUITY SEVERAL TIMES WITH BOTH PASSING AND FAILING RESULTS. THE DEVICE WAS DISASSEMBLED IN EFFORT TO DETERMINE ROOT CAUSE. THE ENTIRE COIL LENGTH UNDER MAGNIFICATION FOR A BROKEN COIL THAT MIGHT OPEN THE CIRCUIT IF THE CABLE IS POSITIONED A CERTAIN WAY. THERE WERE NO PARTIALLY BROKEN COILS. THE SOLDER JOINT IS ALSO INTACT AND THE LINK WIRES STILL ATTACHED TO EACH CUP. ALL HANDLE COMPONENTS ARE IN THEIR PROPER POSITION. NO OTHER ANOMALIES WERE OBSERVED. THE DEVICE HISTORY RECORDS FOR THE PACKAGING WORK ORDER WERE REVIEWED. THE PWO CONSISTED OF ONE ASSEMBLY ORDER (AO) THIS AO WAS MANUFACTURED IN MARCH OF 2016. 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. BASED ON THE DEVICE EVALUATION, THIS INCIDENT NO LONGER MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: DURING OUR EVALUATION, THE FORCEP CUPS WERE VISUALLY EVALUATED AND POTENTIAL CUP MISALIGNMENT WAS 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 FOLLOW UP REPORT WILL BE SENT WHEN THE SUPPLIER EVALUATION IS RECEIVED. 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. INSTRUCTION FOR USE SPECIFY TO OPEN AND CLOSE CUPS TO VERIFY SMOOTH HANDLE OPERATION AND APPROPRIATE CUP ACTION AND IF ANY IRREGULARITIES ARE NOTED TO NOT USE. "EXERCISING HANDLE WHILE FORCEPS IS COILED MAY RESULT IN DAMAGE TO FORCEPS." THE INSTRUCTIONS FOR USE STATE "FORCEPS CUPS MUST REMAIN CLOSED DURING INTRODUCTION INTO, ADVANCEMENT THROUGH, AND REMOVAL FROM ENDOSCOPE. IF CUPS ARE OPEN, DAMAGE TO FORCEPS AND ENDOSCOPE MAY OCCUR." THE INSTRUCTIONS FOR USE STATE: "WITH CUPS CLOSED, INSERT FORCEPS INTO ACCESSORY CHANNEL OF ENDOSCOPE. NOTE: KEEP END OF FORCEPS THAT IS EXTENDING FROM ACCESSORY CHANNEL STRAIGHT AT ALL TIMES. ALLOWING FORCEPS TO HANG FROM ACCESSORY CHANNEL MAY CAUSE DAMAGE TO DEVICE." IF EXCESSIVE PRESSURE WAS APPLIED DURING ADVANCEMENT INTO THE TISSUE OR DURING HANDLE MANIPULATION, THIS COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION. PRIOR TO DISTRIBUTION, ALL CAPTURA HOT BIOPSY FORCEPS 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 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.

    Description of Event or Problem · 1

    THIS CORRECTION FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS. POTENTIAL CUP MISALIGNMENT WAS OBSERVED DURING THE DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832350 CAPTURA HOT BIOPSY FORCEPS KGE, FORCEPS, BIOPSY, ELECTRIC KGE COOK ENDOSCOPY 00827002315839

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ENDOSCOPE UNKNOWN MAKE OR MODEL