BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA - STAPLER

    MDR report key: 3080397 · Received April 23, 2013

    Report

    Report Number
    MW5029930
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 17, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO GIA UNIVERSAL 12 MM - STAPLER FIRED WITHOUT ANYONE INITIATING THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173906 ENDO GIA - STAPLER NONE GDW COVIDIEN 030449 N2K0622X

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention