BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1081242 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00543
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 16, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: VATS. ACCORDING TO THE REPORTER: USING THE ENDO GIA UNIVERSAL WITH A 60-3.5 ROTICULATOR, THE FIRST APPLICATION FOR WEDGE WAS OK. THE KNIFE CUT THE TISSUE DURING THE SECOND APPLICATION, BUT NO STAPLES WERE FORMED IN B-SHAPE. THE KNIFE CUT TWO SEGMENTARY ARTERIES. BECAUSE OF CONVERSION AND BLEEDING, THE OR-TIME EXTENDED TO 2.5 HOURS AND BLOOD WAS TRANSFUSED. THE PATIENT STATUS IS REPORTED AS OK.

    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 N8B449

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention