BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON45, ENDOPATH

    MDR report key: 1883483 · Received October 6, 2010

    Report

    Report Number
    1883483
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AFTER FIRING ECHELON STAPLER 45, IT FAILED TO RELEASE-PER SURGEON.HEALTH PROFESSIONAL'S IMPRESSION: THIS IS THE SECOND TIME THE SURGEON FAILED WITH STAPLER. WILL CALL THE VENDOR TO FOLLOW UP THE SURGEON. UNKNOWN WHETHER USER ERROR OF STAPLER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON45, ENDOPATH STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. EC45 G4RF1W

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR