BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1649769 · Received March 30, 2010

    Report

    Report Number
    MW5015375
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    March 19, 2010
    Report Date
    March 30, 2010
    Manufacturer
    CQ LABS
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS/ENTEROLYSIS, AND LAPAROSCOPIC TUBAL LIGATION -LEFT-, THE THERMACHOICE III BALLOON ABLATION DEVICE WAS PRIMED AND INSERTED. A THERAPY CYCLE WAS INITIATED AND, WITHIN THE WARM UP PHASE, A FAILURE MESSAGE OF THE MOTOR DRIVE OCCURRED AND THE AUDIBLE TURBINE SOUND CONCURRENTLY CEASED. THE BALLOON WAS CHANGED OUT FOR A SECOND BALLOON, WHICH WAS REPRIMED AND INSERTED AND DISTENDED. THE THERAPY CYCLE PROCEEDED UNEVENTFULLY UNINTERRUPTED FOR A FULL 8-MINUTE THERAPEUTIC CYCLE. AFTER COOL DOWN, THE BALLOON WAS COLLAPSED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE UTERINE BALLOON MKN CQ LABS TC003 CBMG02

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability