BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX 60

    MDR report key: 2081850 · Received May 5, 2011

    Report

    Report Number
    MW5020512
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ETHICON ENDOSURGERY LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A LAP ROUX-EN-Y GASTRIC BYPASS. THE STOMACH POUCH WAS BEING FORMED USING SEQUENTIAL FIRINGS OF THE 3.5MM STAPLE LOAD WHEN THERE APPEARED TO BE A MISFIRE. HOWEVER, THE STAPLE LINE WAS EVALUATED CLOSELY AND IT APPEARED TO BE INTACT ON EACH SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FLEX 60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER GDW ETHICON ENDOSURGERY LLC H4315G

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR