BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER XC

    MDR report key: 2810097 · Received October 31, 2012

    Report

    Report Number
    1720381-2012-00058
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 8, 2012
    Report Date
    October 31, 2012
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE EVENT REPORT CONTACTING THE USER FACILITY TO REQUEST PATIENT TREATMENT SETTINGS AND PATIENT PHOTOGRAPHS. THE PATIENT TREATMENT SETTINGS WERE PROVIDED BY THE FACILITY; HOWEVER NO PATIENT PHOTOGRAPHS WERE AVAILABLE. THE USER FACILITY DECLINED SERVICE OF THE SUBJECT DEVICE BY LUMENIS TECHNICAL REPRESENTATIVE. LUMENIS HAS NOT HELD A SERVICE CONTRACT WITH THE USER FACILITY SINCE 07/30/2007. THE USER FACILITY PURCHASED A NEW HANDPIECE ON (B)(4) 2012. A LUMENIS TECHNICAL ENGINEER COMPLETED PERFORMANCE TESTS OF ALL SPECIFICATIONS CONCLUDING THAT THE DEVICE OPERATED TO MANUFACTURER'S SPECIFICATIONS AT THAT TIME. LUMENIS CANNOT RULE OUT THAT SERVICE BY UNAUTHORIZED THIRD PARTY SERVICE PROVIDERS MAY HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. TO THE BEST OF LUMENIS' KNOWLEDGE, THE SUBJECT DEVICE REMAINS IN USE AT THE USER FACILITY. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED TREATMENT SETTINGS CONCLUDING THAT THE REPORTED SETTINGS WERE WITHIN NORMAL LIMITS PER DEVICE TRAINING AND DEVICE IFU, AND THAT THE INFORMATION PROVIDED BY THE USER FACILITY WAS INSUFFICIENT TO MAKE A DETERMINATION OF CAUSE. USER FACILITY DECLINED SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A USER FACILITY THAT A PATIENT OF SKIN TYPE VI SUSTAINED A SECOND DEGREE BURN TO THE GENITAL AREA FOLLOWING A TEST PATCH WITH A LUMENIS LIGHTSHEER XC LASER. NO INFORMATION REGARDING MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER XC SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX RH USA, INC. LIGHTSHEER XC

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other