BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE THERMACHOICE

    MDR report key: 3242464 · Received April 26, 2013

    Report

    Report Number
    3242464
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    "THERMACHOICE" MACHINE NOT FUNCTIONING, UNABLE TO MAINTAIN PRESSURE. A SECOND HAND PIECE OPENED AND HANDED OFF TO THE PHYSICIAN. THE SECOND HAND PIECE WAS NOT FUNCTIONING. THE PHYSICIAN WAS UNABLE TO PERFORM "THERMACHOICE" ABLATION; HOWEVER, ELECTED TO PERFORM UTERINE ABLATION UTILIZING AN ALTERNATIVE UTERINE ABLATION. PATIENT TOLERATED PROCEDURE WELL. "THERMACHOICE" GENERATOR REMOVED FROM SERVICE, TAGGED, BIOMED WAS NOTIFIED. HAND PIECES AND PACKAGING SAVED. BIOMED CHECKED GENERATOR/HAND PIECES. GENERATOR GIVEN ALL CLEAR AND PLACED BACK IN SERVICE. ACCORDING TO BIOMED HAND PIECES ONE HAD A PIN HOLE AND ONE SEAL CRACKED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UTERINE ABLATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183345 GYNECARE THERMACHOICE DEVICE, THERMAL ABLATION MKN ETHICON, INC. TC003 DPMG05

    Patients

    Seq Age Sex Outcome Treatment
    1 *