BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2221616 · Received August 19, 2011

    Report

    Report Number
    1219930-2011-00715
    Event Type
    Injury
    Date Received
    August 19, 2011
    Report Date
    August 12, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: VATS. ACCORDING TO THE REPORTER: THE DEVICE JAMMED. THE INSTRUMENT WAS UNABLE TO BE RELOADED AFTER AN INITIAL FIRING. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC NOR WAS THERE UNINTENDED TISSUE LOSS. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    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 030449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other