BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDAP PROSTATRON

    MDR report key: 298368 · Received September 29, 2000

    Report

    Report Number
    298368
    Event Type
    Malfunction
    Date Received
    September 29, 2000
    Date of Event
    September 15, 2000
    Report Date
    September 28, 2000
    Manufacturer
    EDAP TECHNOMED, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRANSURETHRAL MICROWAVE THERMOTHERAPY WAS BEING ATTEMPTED WHEN PROSTATRON MACHINE MALFUNCTIONED. MACHINE GAVE "ERROR CODE" 309.01 AND WOULD NOT WORK. ANOTHER PROBE WAS OPENED AND PROCEDURE ATTEMPTED 9 MINS INTO PROCEDURE MACHINE STOPPED. ERROR CODE OF 329.01. PROCEDURE ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDAP PROSTATRON PROSTATRON MACHINE MEQ EDAP TECHNOMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other