BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER DELIVERY SYSTEM

    MDR report key: 797845 · Received November 28, 2006

    Report

    Report Number
    797845
    Event Type
    Malfunction
    Date Received
    November 28, 2006
    Date of Event
    November 16, 2006
    Report Date
    November 28, 2006
    Manufacturer
    SURGICAL LASER TECHNOLOGIES, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EXCISION OF LESIONS ON THE FLOOR OF HER MOUTH USING A LASER. THE LASER WAS SET FOR 20 WATTS, AND THE SURGEON PERIODICALLY CLEANED THE TIP OF THE LASER FIBER PER PROTOCOL. THE SURGEON NOTICED THAT THE AIMING BEAM WAS GONE AND THERE WAS NO TISSUE RESPONSE TO THE LASER. AT THE SAME TIME, HE ALSO NOTED THE FIBER-OPTIC WAS GETTING HOT AND BECOMING DISCOLORED. HE STOPPED THE PROCEDURE, SWITCHED OUT THE EQUIPMENT AND EVALUATED THE PATIENT WHO HAD A SMALL BURN ON THE MUCOSA OF HER LIP. IT WAS IMMEDIATELY TREATED, AND HAS SINCE HEALED WITH NO SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBER DELIVERY SYSTEM LASER, FIBER GEX SURGICAL LASER TECHNOLOGIES, INC. * 521303

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR