BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX 60

    MDR report key: 1981907 · Received January 28, 2011

    Report

    Report Number
    1981907
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    PROBABLE MISFIRE NOTED AND REMEDIED. MISFORMED STAPLES NOTED NEAR STAPLE LINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR