BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILSON-COOK MEDICAL

    MDR report key: 418007 · Received September 19, 2002

    Report

    Report Number
    MW1026235
    Event Type
    Malfunction
    Date Received
    September 19, 2002
    Date of Event
    September 10, 2002
    Report Date
    September 19, 2002
    Manufacturer
    WILSON-COOK MEDICAL
    Product Code
    FDR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOWEEL-DASHII DIRECT ACCESS SYSTEM DID NOT BOW SO IT WAS UNABLE TO CUT DURING ENDOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON-COOK MEDICAL HOWEEL-DASHII DIRECT ACCESS SYSTEM FDR WILSON-COOK MEDICAL DASH-480 1626219

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR