BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA UITRA

    MDR report key: 2012128 · Received March 3, 2011

    Report

    Report Number
    2012128
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A THORASCOPIC LUNG RESECTION THE ENDO GIA STAPLER AND STAPLE LOAD MALFUNCTIONED. NEW LOAD OPENED AND STILL MALFUNCTIONED. NEW HANDLE, NEW LOAD OPENED AND IT WORKED AS EXPECTED.MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, ENDO GIA ULTRA: OTHER FACILITIES HAVE HAD SIMILAR PROBLEMS AND HAVE BEEN IN CONTACT WITH THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UITRA STAPLER, SURGICAL GDW COVIDIEN EGIAUSTND N1A0214UK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR