BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2

    MDR report key: 3922810 · Received June 10, 2014

    Report

    Report Number
    3922810
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ETHICON ENDO-SURGERY INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    HARMONIC BOX ALARMED THREE TIMES TO REPOSITION DEVICE FOLLOWED BY AN ALARMED TO REPLACE THE DEVICE. THE EQUIPMENT WAS SENT FOR EVALUATION. THE REPRESENTATIVE WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337473 ENSEAL G2 ELECTROSURGICAL, CUTTING, COAGULATION GEI ETHICON ENDO-SURGERY INC. NSLG2C35 K4D937

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR