BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1033863 · Received April 24, 2008

    Report

    Report Number
    1219930-2008-00320
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 1, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEX: UNK. PROCEDURE: VATS BULLECTOMY. ACCORDING TO THE REPORTER: ON THE SEVENTH FIRING, THE HANDLE MADE A CRACKING NOISE AND THE DEVICE STOPPED WHILE FIRING. THE SURGEON RETRACTED THE BLACK RETURN KNOB, AND BLEEDING OCCURRED FROM THE STAPLE LINE. BLOOD LOSS WAS REPORTED AS BETWEEN 200CC AND 500CC. ANOTHER CARTRIDGE WAS USED TO RE-FIRE BUT IT WOULD NOT CLOSE THE POOR STAPLE LINE COMPLETELY. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. PT STATUS REPORTED AS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N7L240

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention