BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS COMPACT - FLEX 45

    MDR report key: 2182296 · Received July 22, 2011

    Report

    Report Number
    MW5021500
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC JOHNSON AND JOHNSON CO.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER FIRING, THE DEVICE WOULD NOT RELEASE THE TISSUE/PULMONARY VEIN. NO HARM OR ADVERSE OUTCOME TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS COMPACT - FLEX 45 STAPLER GDW ETHICON ENDO-SURGERY, LLC JOHNSON AND JOHNSON CO. REF ATS 45 H43V27

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR