BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUET TRS 60 3.5MM ARTICULATING SULU

    MDR report key: 1871980 · Received October 8, 2010

    Report

    Report Number
    1219930-2010-00783
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K080898
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: WHILE FIRING THE LAST LOAD ON THE SLEEVE AROUND THE ANGLE OF HISS, THE DEVICE CUT BUT DID NOT STAPLE APPROX 1/4 OF THE TISSUE AT THE PROXIMAL END ON ONE SIDE. STAPLES DID FORM AT THE DISTAL END AND THE ENTIRE LENGTH OF THE OTHER SIDE OF THE STAPLE LINE. THE SURGEON WAS ABLE TO GATHER THE TISSUE THAT HAD NOT BEEN STAPLED, AND APPLIED ONE SIDE OF A TRI-STAPLE RELOAD USING A PARTIAL FIRING CYCLE. THE SURGEON THEN OVER SEWED THE AREA AND APPLIED FIBRAN GLUE. OPERATING ROOM TIME WAS DELAYED OVER 30 MINUTES BUT NOT MORE THAN 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET TRS 60 3.5MM ARTICULATING SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0F0656

    Patients

    Seq Age Sex Outcome Treatment
    1