BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 1243793 · Received November 18, 2008

    Report

    Report Number
    1243793
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 18, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMING A LAPAROSCOPIC APPENDECTOMY AND ENDO GIA STAPLER MISFIRED. STAPLE LINE WAS ONLY HALFWAY ACROSS THE TISSUE BEING STAPLED. THERE WAS A SMALL BLEEDER DUE TO INEFFECTIVE STAPLE LINE. BLEEDING CONTROLLED BY CAUTERY AND ENDOLOOPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA STAPLER, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * N8J192

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR NO OTHER THERAPIES| NO OTHER THERAPIES