BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 371404 · Received January 11, 2002

    Report

    Report Number
    2210968-2002-00014
    Event Type
    Malfunction
    Date Received
    January 11, 2002
    Date of Event
    November 15, 2001
    Report Date
    December 14, 2001
    Manufacturer
    GYNECARE INC.
    Product Code
    MKN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UTERINE ABLATION PROCEDURE, THREE CATHETERS WOULD NOT MAINTAIN PRESSURE. A FOURTH DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THE PROCEDURE WAS EXTENDED FOR 1 HOUR AND THE PATIENT WAS UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER II MKN GYNECARE INC. NA 0068791116

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN