BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2

    MDR report key: 3113378 · Received April 23, 2013

    Report

    Report Number
    3113378
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    April 22, 2013
    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

    THERE WAS A FAILURE OF THE DEVICE TO CLOSE. THE GREY BUTTON FELL OFF THE DEVICE AND THE BLADES DID NOT CLOSE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175378 ENSEAL G2 ELECTROSURGICAL, CUTTING, COAGULATION GEI ETHICON ENDO-SURGERY, INC. NSLG2C35 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR