BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE III

    MDR report key: 2110643 · Received May 23, 2011

    Report

    Report Number
    2110643
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US

    Narratives

    Description of Event or Problem · 1

    DURING THE THERMACHOICE PROCEDURE, THE HANDPIECE HAD AN AIRLEAK AND WOULDN'T READ THE CORRECT PRESSURE TO BEGIN THE CASE. SURGEON SWITCHED THE PROCEDURE TO ANOTHER MANUFACTURER AND DEVICE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THERE WAS A MALFUNCTION WITH THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE III THERMACHOICE III MNB ETHICON, INC. 20 BAMG19

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR