BEUDAMED
    FDA Adverse Event Summary report: N

    ENDO GIA ULTRA UNIVERSAL

    MDR report key: 3181372 · Received June 19, 2013

    Report

    Report Number
    3181372
    Date Received
    June 19, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 19, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THORACIC SURGERY. WHEN STAPLER WAS ACTIVATED, IT WOULD NOT RELEASE LOAD. ANOTHER DEVICE WAS OBTAINED TO CONTINUE THE PROCEDURE. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THORACIC.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277937 ENDO GIA ULTRA UNIVERSAL STAPLE, IMPLANTABLE GDW COVIDIEN EGIAUSTND N3D0225UX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR