BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 1247863 · Received November 22, 2008

    Report

    Report Number
    1247863
    Event Type
    Malfunction
    Date Received
    November 22, 2008
    Date of Event
    October 16, 2008
    Report Date
    November 22, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOCTOR ATTEMPTED TO USE ENDO GIA STAPLER # 030449 AND LOAD OF 30 2.5 # 030451 THAT DID NOT WORK. REPLACED WITH NEW ENDO GIA STAPLER AND A NEW LOAD, WHICH WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * N8H408
    2 ENDO GIA RELOAD, STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * N8F415 OR N8H309

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR