BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNCARE THERMACHOICE III

    MDR report key: 3250743 · Received June 7, 2013

    Report

    Report Number
    3250743
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MACHINE READ "OVERHEATING" TWICE. CHANGED DISPOSABLE PIECE AND CHANGED VOLUME OF D5W FOR PRIMING FROM 30CC TO 20CC.ANESTHESIA TIME WAS EXTENDED 15-20 MINUTES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TUBAL LIGATION AND ENDOMETRIAL ABLATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254189 GYNCARE THERMACHOICE III DEVICE, THERMAL ABLATION MNB ETHICON, INC * EMMG12

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR