BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER

    MDR report key: 801735 · Received January 3, 2007

    Report

    Report Number
    2914019-2005-00082
    Event Type
    Other
    Date Received
    January 3, 2007
    Date of Event
    March 3, 2005
    Report Date
    January 3, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE LUMENIS SERVICE DEPOT, THERE WAS A SMALL AMOUNT OF DEBRIS ON THE SAPPHIRE TIP. THIS FOREIGN MATERIAL APPEARS TO BE THE ROOT CAUSE OF THE INCIDENT. PER THE SERVICE DEPOT, THE DEVICE ENERGY WAS WITHIN SPECIFICATIONS. THE SERVICE DEPOT CLEANED THE DEBRIS OFF THE SAPPHIRE TIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 3 PTS BURNED OR BLISTERED IN 2005. THIS WAS THE FIRST LIGHTSHEER HAIR REMOVAL TREATMENT FOR PTS JP AND JS AND THE SECOND LIGHTSHEER HAIR REMOVAL TREATMENT FOR PT WH. PER THECUSTOMER, NONE OF THE PTS REC'D MEDICAL INTERVENTION FOR THE BURNS.

    Description of Event or Problem · 2

    CUSTOMER REPORTED 3 PTS BURNED OR BLISTERED BETWEEN 01/28/2005 - 03/01/2005. THIS WAS THE FIRST LIGHTSHEER HAIR REMOVAL TREATMENT FOR PTS JP AND JS AND THE SECOND LIGHTSHEER HAIR REMOVAL TREATMENT FOR PT WH. PER THE CUSTOMER, NONE OF THE PTS REC'D MEDICAL INTERVENTION FOR THE BURNS.

    Description of Event or Problem · 3

    CUSTOMER REPORTED 3 PTS BURNED OR BLISTERED IN 2005. THIS WAS THE FIRST LIGHTSHEER HAIR REMOVAL TREATMENT FOR PTS JP AND JS AND THE SECOND LIGHTSHEER HAIR REMOVAL TREATMENT FOR PT WH. PER THE CUSTOMER, NONE OF THE PTS REC'D MEDICAL INTERVENTION FOR THE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SURGICAL LASERS GEX LUMENIS, INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other PHOTOSENSITIZING TREATMENT - NO. ALL 3 PTS DENIED| USING ANY PHOTOSENSITIZING MEDICINE.
    2 26 YR Other
    3 39 YR Other