BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX

    MDR report key: 3131013 · Received May 16, 2013

    Report

    Report Number
    3131013
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218366 ECHELON FLEX STAPLER, SURGICAL, LINEAR CUTTER GDW ETHICON ENDO-SURGERY, INC. * K4CA5C

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR
    2