BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1790116 · Received August 2, 2010

    Report

    Report Number
    1219930-2010-00598
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 28, 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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: THE SURGEON USED ONE CARTRIDGE ON THE PULMONARY PARENCHYMA AND THE INSTRUMENT LOCKED ON TISSUE. THE SURGEON WAS ABLE TO ACTIVATE THE DEVICE TO THE END BUT WAS NOT ABLE TO RETRACT THE BLACK KNOBS TO OPEN THE JAWS. THE SURGEON HAD TO PULL OFF THE DEVICE AND TORE THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE ARE NO DETAILS AVAILABLE ABOUT ANY MEDICAL INTERVENTION OR THE AMOUNT OF TISSUE LOST OR CURRENT STATUS OF THE PT.

    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 N0D0505

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability ENDO GIA ROTICULATOR 30-2.5 SULU| 030451, LOT #: N9M0208| EXP DATE: 12/31/2014, MFR DATE: 12/2009