BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 2141474 · Received June 23, 2011

    Report

    Report Number
    2141474
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ECHELON FLEX 60 SC60A STAPLER WAS BEING USED IN A VENA CAVA RECONSTRUCTION AND THE STAPLE LINE CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. SC60A H43F51

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR