BEUDAMED
    FDA Adverse Event Summary report: N

    ECHELON FLEX 60

    MDR report key: 2082690 · Received May 4, 2011

    Report

    Report Number
    2082690
    Date Received
    May 4, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON USED AN ECHELON FLEX 60 STAPLER ON A PATIENT PERFORMING A LAPAROSCOPICSIGMOID COLECTOMY AND THE STAPLER MISFIRED LEAVING THE INTENDED STAPLE SITE WITH AN INCOMPLETE STAPLE LINE. THE STAPLER WAS IMMEDIATELY REMOVED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FLEX 60 STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. EC60A H43G48

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR