BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUET TRS 60 4.8MM STRAIGHT SULU

    MDR report key: 1760427 · Received July 13, 2010

    Report

    Report Number
    1219930-2010-00544
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 12, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K080898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: DURING THE SECOND FIRING TO CREATE A GASTRIC POUCH, THE STAPLE CARTRIDGE DISENGAGED FROM THE CHANNEL DURING THE FIRING. THE HANDLE LOCKED THE LOAD DOWN AND THE SURGEON WAS UNABLE TO MANUALLY PULL THE LOAD OFF. THE STAFF HAD TO OPEN ANOTHER HANDLE AND LOAD AND FIRED AROUND LOCKED LOAD TO GET IT OUT OF THE PATIENT. THE SURGEON CHOSE NOT TO RETRACT THE INSTRUMENT RETURN KNOBS AND RESECTED THE JAWS AS HE WAS UNABLE TO PULL THE JAWS OFF FROM TISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability