BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE GYNERCARE

    MDR report key: 1912772 · Received November 22, 2010

    Report

    Report Number
    1912772
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    July 20, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ETHICON HEI INC ADVANCED MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT FOR DIAGNOSTIC HYSTEROSCOPY WITH ENDOMETRIAL BIOPSY AND THERMAL ABLATION. DIAGNOSTIC HYSTEROSCOPY AND BIOPSY PERFORMED. DURING ABLATION, PHYSICIAN WAS UNABLE TO GET THE TEMP TO RISE ON THE THERMAL ABLATION UNIT. UMBILICAL CORD CHANGED, BALLOON WAS DRAINED; THE UNIT WAS RE-PRIMED AND THEN PLACED BACK IN AGAIN TO APPROXIMATELY 10 CM EXTRACTED BACK TO 9 CM. UNIT AGAIN RELATED A LOW PRESSURE. AT THIS TIME, IT WAS OPTED TO DEFLATE THE BALLOON AND EXTRACT IT OUT AND GET A WHOLE NEW THERMACHOICE UNIT, SO AT THIS POINT ON THE THIRD ATTEMPT WITH A NEW UMBILICAL LINE AND A NEW THERMACHOICE UNIT, AND THE BALLOON PRIMED AGAIN PLACED INTO THE UTERUS AND THE SAME THING HAPPENED AND THE MACHINE STARTED TO CHIME THAT THE TEMP WAS LOW. THE PRESSURE WAS APPROXIMATELY 170 TO 175. PHYSICIAN STATED HE FELT THE PROBLEM WAS WITH THE THERMACHOICE MACHINE ITSELF, THEREFORE, THE ABLATION PROCEDURE WAS ABORTED DUE TO NO OTHER THERMACHOICE MACHINE. JOHNSON AND JOHNSON REP NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE GYNERCARE THERMACHOICE GEI ETHICON HEI INC ADVANCED MEDICAL EAS2001-1

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR