BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH ETS-FLEX45

    MDR report key: 1590762 · Received January 28, 2010

    Report

    Report Number
    MW5014544
    Event Type
    Death
    Date Received
    January 28, 2010
    Date of Event
    January 18, 2010
    Report Date
    January 21, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC, CORPORATE HEADQUARTERS
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON PLACED ENDOSCOPIC LINEAR STAPLER ACROSS VESSEL/TISSUE TO STAPLE AND LIGATE. STAPLER JAWS WERE PLACED ACROSS VESSEL/TISSUE, DEVICE WAS LOCKED AND THE DEVICE WAS ACTIVATED. UPON RELEASE OF THE JAWS, PROFUSE BLEEDING BEGAN. THE DEVICE DID NOT APPEAR TO ENGAGE STAPLES PRIOR TO CUTTING THE TISSUE. LIFE SAVING MEASURES WERE IMPLEMENTED. PT PASSED AWAY APPROXIMATELY 10 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS-FLEX45 ARTICULATING ENDOPATHIC LINEAR CUTTER KOG ETHICON ENDO SURGERY, INC, CORPORATE HEADQUARTERS ATS45 F4R38Y

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death