BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLTOUCH MODEL 500R FIBER OPTIC

    MDR report key: 2392264 · Received November 29, 2007

    Report

    Report Number
    2951571-2007-00001
    Event Type
    Malfunction
    Date Received
    November 29, 2007
    Date of Event
    November 15, 2007
    Report Date
    November 29, 2001
    Manufacturer
    NEW STAR LASERS, INC., DBA COOLTOUCH, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP CONFIRMED "GREEN STICK" BREAK (FIBER OPTIC BROKE DUE TO EXCESS PRESSURE EXERTED ON IT). FIBER WAS REPLACED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING CONVENTIONAL LIPOSUCTION ON THE PT'S ABDOMEN IN CONJUNCTION WITH A 1320 NM LASER. DURING THE PROCESS OF APPLYING THERMAL HEATING IN A STANDARD MANNER AND AT THE POINT WHERE THE FIBER OPTIC EXITS THE HANDPIECE, THE FIBER HAD PUSHED AGAINST THE DOCTOR AND THE FIBER BROKE UNNOTICED. WITH THE LASER STILL FIRING, THE BROKEN FIBER PIECE FELL TO THE FLOOR, BRUSHING THE PAPER DRAPES AND IGNITING THEM. THE PHYSICIAN AND ATTENDANT ATTEMPTED TO EXTINGUISH THE FLAMES BY SMOTHERING THEM BUT WERE UNSUCCESSFUL. STAFF GRABBED A FIRE EXTINGUISHER AND THE FIRE WAS EXTINGUISHED. THE PT WAS UNHARMED AND REMOVED TO ANOTHER ROOM, WHERE A NEW FIBER WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLTOUCH MODEL 500R FIBER OPTIC COOLTOUCH FIBER OPTIC GEX NEW STAR LASERS, INC., DBA COOLTOUCH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR