BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUET TRS 60 4.8MM ARTICULATING SULU

    MDR report key: 1772156 · Received July 22, 2010

    Report

    Report Number
    1219930-2010-00567
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 19, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K080898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE ON THE THIRD FIRING, THE MIDDLE OF THE STAPLE LINE WAS MALFORMED. THE DEVICE FELT STIFF WHEN SQUEEZING THE HANDLE. ADDITIONAL RESECTION OF TISSUE OCCURRED AND THE STAFF USED ANOTHER DEVICE TO COMPLETE THE CASE.

    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 N0D0290

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability EXP DATE: 04/30/2015, MANUFACTURE DATE: 04/2010| 030403, GIA UNIVERSAL, LOT NUMBER: N0D0610