BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2864468 · Received December 5, 2012

    Report

    Report Number
    1037905-2012-00668
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 18, 2012
    Report Date
    November 8, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL CONFIRMED THE REPORT, THE DRIVE WIRE HAS DETACHED IN THE HANDLE. THE RETURNED DEVICE WAS SENT TO THE APPROVED SUPPLIER FOR EVAL. THE SUPPLIER PROVIDED THE FOLLOWING INFO: THE DEVICE WAS RETURNED WITH THE DRIVE WIRE REMOVED FROM THE HANDLE - NO FUNCTIONAL TESTING COULD BE CONDUCTED. THE EVAL SHOWED THAT THE CLIP WAS DETACHED AND NOT RETURNED, THE DRIVE WIRE WAS BENT AND NO LONGER ATTACHED TO THE HANDLE. THE HANDLE WAS DISASSEMBLED AND INSPECTED UNDER MICROSCOPE. THE CONNECTOR AND DRIVE WIRE ASSEMBLY WERE VERIFIED TO BE WITHIN THE APPROPRIATE MANUFACTURING SPECS. THERE WERE NO DEFECTS OBSERVED ON ANY OF THE COMPONENTS RETURNED WITH THE DEVICE. 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 CONCLUSIONS: 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 PT 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. PRIOR TO DISTRIBUTION, ALL DISPOSABLE HEMOSTASIS CLIPS 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

    DURING A CLIPPING PROCEDURE, A COOK DISPOSABLE HEMOSTASIS CLIP WAS USED. THE CLIP WAS DEPLOYED (ATTACHED TO THE TISSUE SITE AND RELEASED FROM THE DEPLOYMENT DEVICE). AFTER DEPLOYMENT, THE HOOK (OF THE DEPLOYMENT DEVICE'S INNER DRIVE WIRE) WOULD NOT STAY INSIDE THE (OUTER) SHEATH FOR REMOVAL (FROM ENDOSCOPE). THE DEVICE WAS REMOVED VERY PAINSTAKINGLY. THERE WAS NO HARM TO THE PT OR THE ENDOSCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE HEMOSTASIS CLIP MND, LIGATOR, HEMORRHOIDAL MND WILSON-COOK MEDICAL INC W3188857

    Patients

    Seq Age Sex Outcome Treatment
    1 FUJINON ENDOSCOPE (UNKNOWN MODEL NUMBER)