BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1820721 · Received August 27, 2010

    Report

    Report Number
    1219930-2010-00674
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE DR FIRED THE DEVICE BUT NO STAPLES DISCHARGED AT THAT TIME. THE BLADE DID NOT CUT PROPERLY AND IT PUSHED THE TISSUE OUT FROM THE STAPLER. THREE OF THE 45 BLUE ROTICULATOR RELOADS DID NOT OPEN.

    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 N0E0304

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability ENDO GIA ROTICULATOR, (B)(4), 45-3.5 SULU