BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTAPROBE

    MDR report key: 274148 · Received April 14, 2000

    Report

    Report Number
    1287394-2000-00053
    Event Type
    Malfunction
    Date Received
    April 14, 2000
    Date of Event
    February 7, 2000
    Report Date
    April 14, 2000
    Manufacturer
    EDAP TECHNOMED, SA/PARC D"ACTIVITIES LA POUD-LAMAR
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EIGHT AND HALF MINUTES INTO A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, PHYSICIAN SAW RECTAL TEMPERATURES GOING UP FAST, THEN DIVERTING. CHECKED RECTAL PROBE AND NOTICED THAT IT HAD SLIPPED OUT OF RECTUM. PHYSICIAN REPOSITIONED RECTAL PROBE. PHYSICIAN THEN NOTICED CLOTTING ON THE TIP OF THE PENIS. PHYSICIAN WIPED THE MEATUS AND THE CATHETER MOVED. PHYSICIAN HIT "ESCAPE" AND STOPPED THE TREATMENT. PHYSICIAN THEN PULLED ON THE CATHETER AND IT SLIPPED OUT. PHYSICIAN REMOVED CATHETER AND BALLOON WAS DEFLATED. PHYSICIAN STOPPED TREATMENT BEFORE THE CATHETER HAD A CHANCE TO MIGRATE. PHYSICIAN PERFORMED ULTRASOUND AT THE BEGINNING OF TREATMENT AND CATHETER WAS PROPERLY POSITIONED. PHYSICIAN PLACED 2ND CATHETER BUT THEN DECIDED TO STOP THE TREATMENT AFTER HAVING SOME CALIBRATION DIFFICULTIES. THE PHYSICIAN PERFORMED A FLEXIBLE CYSTOSCOPY ON THE PT AND IRRIGATED PT'S BLADDER. PHYSICIAN CHECKED URETHRA. IT LOOKED GOOD WITH A LITTLE BLEEDING WHICH IS NORMAL FOLLOWING PASSAGE OF THE CATHETER. THIS EVENT IS BEING REPORTED BECAUSE A SIMILAR EVENT COULD RESULT IN A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAPROBE ACCESSORY CATHETER FOR BPH MICROWAVE HYPERTHERMINA SYSTEM MEQ EDAP TECHNOMED, SA/PARC D"ACTIVITIES LA POUD-LAMAR NA 99012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other