BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE CLIP APPLIER

    MDR report key: 2771616 · Received September 26, 2012

    Report

    Report Number
    MW5027110
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    July 2, 2012
    Report Date
    September 26, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILED TO FORM CLIPS AS SURGEON ATTEMPTED TO CLOSE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE CLIP APPLIER DISPOSABLE LAPROSCOPIC CLIP APPLIER GDO APPLIED MEDICAL 10 MM 1163381

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR