BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER EC

    MDR report key: 2717993 · Received August 28, 2012

    Report

    Report Number
    1720381-2012-00052
    Event Type
    Injury
    Date Received
    August 28, 2012
    Date of Event
    June 14, 2012
    Report Date
    August 22, 2012
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS OBTAINED CONTACT INFORMATION FOR THE USER FACILITY AND CONTACTED THE FACILITY TO INVESTIGATE THE EVENT REPORT. REASONABLE ATTEMPTS WERE MADE TO OBTAIN TREATMENT SETTINGS AND OTHER RELEVANT INFORMATION FROM THE FACILITY; HOWEVER, THE FACILITY DID NOT RESPOND TO REQUESTS FOR INFORMATION. THE PATIENT PROVIDED BEFORE AND AFTER PHOTOGRAPHS OF THE TREATED AREA. NO EVALUATION OF THE SUBJECT DEVICE OCCURRED; A REVIEW OF SUBJECT DEVICE SERVICE RECORDS FOUND THAT THE DEVICE HAD NOT BEEN SERVICED BY LUMENIS SINCE ORIGINAL INSTALLATION IN (B)(6) 2005. THE USER FACILITY HAS NOT MAINTAINED NOR DOES IT MAINTAIN A SERVICE CONTRACT WITH LUMENIS. A REVIEW OF THE RELEVANT 510(K) FOR THE SUBJECT DEVICE, K00361, FOUND THAT THE DEVICE IS NOT CLEARED FOR TATTOO REMOVAL TREATMENT. THE SUMMARY STATEMENT STATES THE FOLLOWING INFORMATION: THE LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM IS INTENDED FOR THE TREATMENT OF VASCULAR LESIONS, INCLUDING ANGIOMAS, HEMANGIOMAS, TELANGIECTASIA AND OTHER BENIGN VASCULAR LESIONS, AND THE TREATMENT FOR PSEUDOFOLLICULITIS BARBAE. THE LIGHTSHEER IS ALSO INDICATED FOR HAIR REMOVAL, PERMANENT HAIR REDUCTION, AND THE TREATMENT OF BENIGN PIGMENTED LESIONS AND LEG VEINS. THE LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM IS INTENDED FOR USE ON ALL SKIN TYPES (FITZPATRICK SKIN TYPES I - VI), INCLUDING TANNED SKIN. A REVIEW OF THE DEVICE LABELING FOUND NO GUIDELINES FOR TATTOO REMOVAL TREATMENT. A LUMENIS HEALTHCARE PROVIDER REVIEWED THE REPORTED EVENT DETAILS AND PATIENT PHOTOGRAPHS. THE HEALTHCARE PROVIDER STATED THAT SUBJECT DEVICE TRAINING INCLUDES SPECIFIC INFORMATION CAUTIONING DEVICE OPERATORS TO AVOID TREATING THE AREA AROUND A TATTOO WHEN EMPLOYING THE SUBJECT DEVICE FOR CLEARED TREATMENTS. LUMENIS CONCLUDES THE ROOT CAUSE OF THE REPORTED EVENT TO BE OPERATOR ERROR, OFF-LABEL USE OF THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT ON VOLUNTARY MEDWATCH (B)(4) THAT THEY SUSTAINED A FULL THICKNESS BURN TO THE LEG AS A RESULT OF TATTOO REMOVAL TREATMENT PERFORMED USING A LUMENIS LIGHTSHEER XC LASER. THE PATIENT REPORTED THAT MEDICAL INTERVENTION BY THEIR PERSONAL DERMATOLOGIST WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R