BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER

    MDR report key: 2102324 · Received May 19, 2011

    Report

    Report Number
    MW5020694
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO DEPLOY STAPLER DURING SURGICAL PROCEDURE AND THE HANDLE BROKE. UNABLE TO DEPLOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER ENDO STAPLER GDW COVIDIEN N1B0773UK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Disability