BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 3212389 · Received June 26, 2013

    Report

    Report Number
    3212389
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    ON FIRST ATTEMPT OF ABLATION WITH THERMACHOICE MACHINE, THE MACHINE WOULD NOT HOLD TEMP AND TREATMENT WAS ABORTED BY MACHINE. THE HANDPIECE HAD A READ ERROR MESSAGE AND WAS ALSO MAKING A CLICKING NOISE. THE DISPOSABLE HAND PIECE WAS CHANGED OUT AND TREATMENT WAS RESTARTED AGAIN. THE TREATMENT WAS NOT ABORTED BY THE MACHINE. THE PROCEDURE WAS COMPLETED, BUT TEMPERATURE DID FLUCTUATE. THERE WAS NO HARM TO THE PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289647 THERMACHOICE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB ETHICON, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR