BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1860366 · Received September 16, 2010

    Report

    Report Number
    1860366
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ETHICON
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO PERFORM ABLATION WITH THE THERMACHOICE II LOANER UNIT, THE UNIT INDICATED OVERHEAT ALARM AND INSTRUCTED TO REMOVE THE BALLOON. NEW DISPOSABLE OPENED AND PRIMED AND PROCEDURE RESTARTED. UNIT PERFORMED APPROXIMATELY FOR 4 MINUTES 23 SECONDS, THEN AGAIN OVERHEATED. UNIT WAS THEN TURNED OFF, RESTARTED AND TREATMENT RESUMED FOR THE REMAINING 3 MINUTES AND 37 SECONDS. UNIT TURNED OFF AND DISPOSABLE REMOVED. DURING PROCEDURE, ETHICON TECH SUPPORT WAS CONTACTED AND REMAINED ON THE PHONE. TECH INSTRUCTED STAFF TO BAG ORIGINAL DISPOSABLE AND SAVE FOR RETURN TO THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE THERMACHOICE BALLOON ABLATION UNIT MNB ETHICON EAS2000-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *