BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH

    MDR report key: 1060224 · Received June 6, 2008

    Report

    Report Number
    1060224
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 6, 2008
    Manufacturer
    ETHICON ENDO-SURGERY INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE FAILED TO FIRE ON THE SECOND USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY INC. * D4JY0C

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR