BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX

    MDR report key: 2071902 · Received April 27, 2011

    Report

    Report Number
    2071902
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    January 11, 2008
    Report Date
    February 14, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ETHICON LINEAR CUTTER WOULD NOT FIRE. IT ALSO MADE A "CLICKING" NOISE WHEN ATTEMPTING TO FIRE. THREE OTHER CUTTERS WERE OPENED AND ALSO FAILED. THE FOURTH CUTTER FUNCTIONED PROPERLY AND THE PROCEDURE PROCEEDED WITHOUT FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATW45 D5JH26
    2 ETS FLEX STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATW45 D5JFON
    3 ETS FLEX STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATW45 C5DT31

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR NO OTHER THERAPIES