BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 1803021 · Received August 11, 2010

    Report

    Report Number
    MW5017097
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PRIMING THE THERMA CHOICE, DR (B)(6) COULD NOT ACHIEVE PROPER NEGATIVE PRESSURE. AIR APPEARED TO BE LEAKING INTO THE ATTACHED SYRINGE AND BALLOON (B)(4). REMOVED FROM THE FIELD AND A SECOND INSTRUMENT WAS OPENED AND USED WITHOUT INCIDENT. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON THERMACHOICE III UTERINE BALLOON THERAPY MKN ETHICON ENDO SURGERY C1027235

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR