BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER ET

    MDR report key: 801654 · Received January 3, 2007

    Report

    Report Number
    2914019-2005-00079
    Event Type
    Other
    Date Received
    January 3, 2007
    Date of Event
    January 6, 2005
    Report Date
    January 3, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE LUMENIS SERVICE DEPOT. PER THE LUMENIS SERVICE DEPOT, THERE WAS A SPOT ON THE OUTSIDE OF THE SAPPHIRE TIP THAT COULD ONLY BE REMOVED BY SCRAPING. AFTER THE SPOT WAS REMOVED, THERE WAS SOME DISCOLORATION ON THE SAPPHIRE TIP THAT COULD NOT BE CLEANED OFF, AND THE TIP WAS REPLACED. THE ENERGY WAS WITHIN SPECIFICATIONS, AND THE COOLING SYSTEM WAS FUNCTIONING PROPERLY. THE FOREIGN MATERIAL ON THE SAPPHIRE TIP APPEARS TO BE THE ROOT CAUSE OF THE INCIDENT. THE SERVICE DEPOT DISCUSSED WITH THE CUSTOMER THE IMPORTANCE OF CLEANING THE SAPPHIRE TIP REGULARLY AND INSPECTING THE TIP OFTEN FOR BUILD UP OF DEBRIS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT WAS INJURED DURING A HAIR REMOVAL TREATMENT. THE PT HAD BURNS AND BLISTERS ON THE SIDES OF THE LEGS. THE BURNS WERE TREATED WITH ANTIBIOTIC OINTMENT (OTC). ACCORDING TO THE PHYSICIAN, FULL RESOLUTION TO INJURY WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER ET LIGHTSHEER GEX LUMENIS, INC. 50-05345 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other NONE REPORTED