BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-4.8 SULU

    MDR report key: 1900126 · Received November 9, 2010

    Report

    Report Number
    1219930-2010-00834
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 15, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE BUTTON ON THE OUTSIDE OF THE CARTRIDGE WHICH MOVES WITH THE KNIFE BLADE CAME OFF THE CARTRIDGE AND FELL INTO THE PT DURING THE SURGEON'S FIRST FIRING OF THE STAPLER. THE SURGEON DID NOT REALIZE THIS PIECE HAD FALLEN OFF UNTIL THE PT WAS IN RECOVERY. THIS METAL BUTTON WAS NOT RECOVERED AND REMAINS INSIDE THE PT. THE SURGEON OVERSEWED THE STAPLE LINE AFTER COMPLETING THE SLEEVE GASTRECTOMY. THE PT WAS SENT HOME FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 60-4.8 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other