BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 2110894 · Received May 27, 2011

    Report

    Report Number
    2110894
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 27, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE ENDO GIA STAPLER, THE STAPLER WAS LOCKED ON THE PULMONARY VEIN AND WOULD NOT RELEASE.MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, ENDO GIA: REQUESTED RETURN FOR REVIEW PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA STAPLER, SURGICAL GDW COVIDIEN * N1B0416
    2 ENDO GIA STAPLER, SURGICAL GDW COVIDIEN * N1B0416

    Patients

    Seq Age Sex Outcome Treatment
    1 *