BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-4.8 SULU

    MDR report key: 2132235 · Received June 14, 2011

    Report

    Report Number
    2647580-2011-00397
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: WEDGE RESECTION. ACCORDING TO THE REPORTER: THE INSTRUMENT WAS PLACED ON LUNG TISSUE, WAS CLOSED AND WAS FIRED. THE INSTRUMENT COULD NOT BE OPENED AFTER FIRING AND HAD TO BE CUT OUT OFF TISSUE. SCISSORS WERE USED TO CUT AROUND THE SULU AND IT WAS REMOVED. A SECOND DEVICE WAS THEN APPLIED AND FIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 60-4.8 SULU DISPOSABLE STAPLER GDW USSC PUERTO RICO P0E0057

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability