BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED ECHELON FEX 60

    MDR report key: 2580027 · Received May 15, 2012

    Report

    Report Number
    2580027
    Event Type
    Malfunction
    Date Received
    May 15, 2012
    Date of Event
    April 28, 2012
    Report Date
    May 15, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER MISFIRED WHEN USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED ECHELON FEX 60 STAPLER, POWERED, SURGICAL GDW ETHICON ENDO-SURGERY, INC. PSE60A J4AF6U

    Patients

    Seq Age Sex Outcome Treatment
    1 *