BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1081234 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00545
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ROBOTIC VATS/WEDGE RESECTION. ACCORDING TO THE REPORTER: THERE WAS DIFFICULTY LOADING/FIRING THE FIRST HANDLE. A SECOND HANDLE WAS OPENED USING THE SAME LOAD. IT FIRED CORRECTLY BUT IT WOULD NOT PULL BACK TO RELEASE OFF TISSUE. TISSUE AROUND THE JAWS WAS CAUTERIZED IN ORDER TO REMOVE THE DEVICE AND COMPLETE THE CASE. OR TIME WAS EXTENDED APPROXIMATELY 30-40 MINUTES.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention