BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2974553 · Received January 29, 2013

    Report

    Report Number
    1037905-2013-00044
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THE DRIVE WIRE HAS SEPARATED INSIDE THE HANDLE. VISUAL EXAMINATION OF THE PROXIMAL END OF THE DRIVE WIRE AND REMOVAL OF THE ANCHOR SCREW UNDER A MICROSCOPE CONFIRMED THE DEVICE WAS MANUFACTURED WITHIN THE APPROPRIATE MANUFACTURING SPECS. THE CLIP HAD BEEN DEPLOYED. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB 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 LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. PRIOR TO DISTRIBUTION, ALL DISPOSABLE HEMOSTASIS CLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. 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 COLONOSCOPY, A COOK DISPOSABLE HEMOSTASIS CLIP WAS USED IN THE SIGMOID COLON TO TREAT A POST POLYPECTOMY BLEED. THE DEVICE WAS ADVANCED THROUGH THE ENDOSCOPE AND THE CLIP WAS ATTACHED TO THE SITE. AFTER SUCCESSFUL DEPLOYMENT OF THE CLIP, THE LITTLE WIRE THAT HOLDS THE CLIP TO THE CATHETER WOULD NOT RETRACT INTO THE OUTER SHEATH OF THE CATHETER [DRIVE WIRE DISCONNECTED FROM THE HANDLE]. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE WITH THE INNER WIRE EXTENDING BEYOND THE OUTER SHEATH. THERE WAS NO REPORT OF DAMAGE TO THE ENDOSCOPE DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L 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
    39771 DISPOSABLE HEMOSTASIS CLIP MND, LIGATOR, HEMORRHOIDAL MND WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS COLONOSCOPE (UNKNOWN MODEL NUMBER)