BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2243854 · Received September 7, 2011

    Report

    Report Number
    1219930-2011-00769
    Event Type
    Injury
    Date Received
    September 7, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 11, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ACCORDING TO THE REPORTER: THE ENDO GIA UNIVERSAL COULD NOT FIRE SUCCESSFULLY AS IT WAS STUCK AND COULD NOT BE REMOVED. THE JOINT OF DUET WAS BROKEN. THE DEVICE WAS REMOVED WITH EXTERNAL FORCE. THERE WAS NO BLOOD LOSS IN EXCESS OF 250CC NOR WAS THERE ANY TISSUE DAMAGE. SURGICAL TIME EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT: UNKNOWN, K061095| DUET TRS 45 3.5MM ARTICULATING SULU: (B)(4)