BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 1894337 · Received November 1, 2010

    Report

    Report Number
    1219930-2010-00823
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 27, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE STAPLER MISFIRED DURING THE CASE, THE KNIFE CUT BUT DID NOT STAPLE AT ALL. BLEEDING OCCURRED, BUT SURGEON OVER SEWED TO STOP BLEEDING. OPERATING ROOM TIME WAS DELAYED 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0J0103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other