BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1984535 · Received February 1, 2011

    Report

    Report Number
    1219930-2011-00078
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 20, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE STAPLER WOULD NOT OPEN WHEN THE TISSUE WAS IN THE CLAMP. HAD TO CAUTERIZE TO RELEASE CLAMP FROM PATIENT.

    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 N9K0096

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability