BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUO TONE SITE LITE

    MDR report key: 748888 · Received October 19, 2005

    Report

    Report Number
    MW1036953
    Event Type
    Other
    Date Received
    October 19, 2005
    Date of Event
    October 6, 2005
    Report Date
    October 12, 2005
    Manufacturer
    LUMENIS DISTRIBUTED VIA FORTEC MEDICAL INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A LASER ABLATION OF THE PROSTATE. THE SURGEON WAS USING THE HOLMIUM LASER UNIT WHEN HE FELT A SHARP PAIN IN HIS RIGHT HAND. WHEN HE REMOVED HIS GLOVE HE NOTICED TWO SMALL BURNS, ONE ON HIS MIDDLE FINGER AND ONE ON HIS INDEX FINGER. THE DISPOSABLE LASER FIBER HAD BECOMED STRIPPED AND BROKEN OFF AT THE SITE WHERE IT EXITS THE CONNECTOR. THE FIBER IS CONNECTED TO THE UNIT VIA AN OBLONG SHAPED RUBBER CONNECTOR. THE SURGEON WAS HOLDING THE CONNECTOR IN HIS RIGHT HAND (AS HE HAS ALWAYS DONE) TO DIRECT THE LASER BEAM. HE WAS TREATED IN EMERGENCY DEPARTMENT. THE BURNS WERE SMALL AND NOT FELT TO BE SERIOUS. TO DATE NO SERIOUS SEQUELAE HAVE DEVELOPED THAT REPORTER IS AWARE OF. THE PATIENT WAS NOT HARMED IN ANY WAY. IT IS FELT THAT THE RISK OF SEROUIS INJURY EXISTS IF THIS MALFUNCTION WAS TO RECUR. THE LASER UNIT IS A RENTAL UNIT. THEY ALSO SUPPLY THE DISPOSABLE LASER FIBER. THE LASER FIBER IS DISTRIUBUTED TO FORTEC MEDICAL INC. VIA BOSTON SCIENTIFIC ADDRESSE UNKNOWN. THE FIBER IS MANUFACTURED BY LUMENIS IN ISRAEL. NO ADDRESS IS AVAILABLE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUO TONE SITE LITE LASER FIBER GEX LUMENIS DISTRIBUTED VIA FORTEC MEDICAL INC. M006840840F 32490805

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other