BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS-FLEX 45

    MDR report key: 1081162 · Received July 23, 2008

    Report

    Report Number
    MW5007774
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS A NEW DEVICE TO THE MARKET. THIS DEVICE DOES NOT HAVE A SAFETY MECHANISM TO PREVENT THE DEVICE FROM FIRING OR CUTTING WHEN THERE ARE NO STAPLES LOADED. THIS DEVICE IS MEANT TO CUT AND STAPLE DURING SURGERY. THERE WERE NO STAPLES LOADED, THE SURGEON WAS UNAWARE, AND THE DEVICE CUT THE VEIN AND ARTERY WITHOUT STAPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS-FLEX 45 ARTICULATING ENDOSCOPIC LINEAR CUTTER GCJ ETHICON ENDO-SURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability