BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUET TRS 60 4.8MM ARTICULATING SULU

    MDR report key: 1844798 · Received September 22, 2010

    Report

    Report Number
    1219930-2010-00730
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    July 1, 2010
    Report Date
    September 6, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K080898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE CARTRIDGE DIDN'T OPEN AFTER FIRING ON THE TISSUE. THE DEVICE WAS PRIED OFF WITH AN ADD'L TOOL W/O BLOOD LOSS OR TISSUE DAMAGE. OPERATING ROOM TIME EXTENSION WAS REPORTED AS APPROX 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET TRS 60 4.8MM ARTICULATING SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0B0279

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ENDO GIA UNIVERSAL XL, EGIAUNIVXL