BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILSON - COOK MEDICAL

    MDR report key: 654742 · Received November 30, 2005

    Report

    Report Number
    MW1037313
    Event Type
    Malfunction
    Date Received
    November 30, 2005
    Date of Event
    November 17, 2005
    Report Date
    November 18, 2005
    Manufacturer
    WILSON - COOK MEDICAL
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING EGD FOR ACTIVE RECTAL BLEEDING. AFTER SEVERAL ATTEMPTS OF ELECTROCAUTERY SCLERO THERAPY NEEDLE WITH EPINIEPHRINE A DECISION BY MD WAS MADE TO USE A CLIPPING DEVICE - WILSON - COOK TRI CLIP TO PROVIDE HEMOSTASIS TO THE ACTIVE BLEEDING SITE. UPON ATTEMPT TO ADVANCE THE CLIP THROUGH THE ENDOSCOPE - THE CLIPPING DEVICE'S HANDLE SPONTANEOUSLY BROKE APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON - COOK MEDICAL TRI CLIP APPARATUS MND WILSON - COOK MEDICAL TC-8-12-S W2018166

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR