BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL GIA 12MM

    MDR report key: 1489231 · Received September 15, 2009

    Report

    Report Number
    1489231
    Event Type
    Malfunction
    Date Received
    September 15, 2009
    Date of Event
    August 13, 2009
    Report Date
    September 15, 2009
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    STAPLER AUTOSUTURE GIA UNIVERSAL, # 030403, LOT N9F0263, EXPIRATION DATE 2014-06, JAMMED AFTER INITIAL FIRING, UNABLE TO RELOAD. INITIAL STAPLE LINE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL GIA 12MM STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * N9F0263

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR