BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1915754 · Received November 29, 2010

    Report

    Report Number
    1219930-2010-00899
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: SURGEON FIRED THE ENDO GIA UNIVERSAL 30-2.5MM WHITE RELOAD ACROSS THE PULMONARY ARTERY. THE RELOAD STAPLED AND THE I-BEAM MOVED TO THE DISTAL END OF THE RELOAD. THE SURGEON WAS UNABLE TO OPEN THE JAWS OF THE RELOAD. THE RELOAD HAD TO BE CUT OFF THE TISSUE IN ORDER TO BE REMOVED FROM THE BODY CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDO GIA ROTICULATOR 30-2.5 SULU, (B)(4)