BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA UNIVERSAL

    MDR report key: 1221363 · Received October 28, 2008

    Report

    Report Number
    1221363
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 28, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT WOULD NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * N30449

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN| NO OTHER THERAPIES| NONE KNOWN| NO OTHER THERAPIES