BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER ET

    MDR report key: 2463914 · Received February 22, 2012

    Report

    Report Number
    1720381-2012-00007
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    February 4, 2012
    Report Date
    February 21, 2012
    Manufacturer
    LUMENIS INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED BLISTERS TO THE INNER THIGH AND KNEE FOLLOWING TREATMENT WITH THE LUMENIS LIGHTSHEER ET LASER. IT WAS FURTHER REPORTED THAT THE PATIENT HAD HEALED WITH NO PERMANENT IMPAIRMENT. NO MEDICAL INTERVENTION WAS REPORTED TO PRECLUDE PERMANENT IMPAIRMENT. THE USER FACILITY DECLINED SERVICE FOR THE SUBJECT DEVICE; THEREFORE NO EXAMINATION OF THE DEVICE OCCURRED. A REVIEW OF SUBJECT DEVICE SERVICE RECORDS FOUND THAT LUMENIS HAS NOT BEEN CONTRACTED BY THE USER FACILITY TO PERFORM SERVICE SINCE (B)(6) 2007. 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 EVENT DETAILS CONCLUDING THE PROBABLE ROOT CAUSE OF THE REPORTED EVENT TO BE DEBRIS BUILD UP ON THE TREATMENT TIP AS A RESULT OF INSUFFICIENT CLEANING BY THE DEVICE OPERATOR IN CONTRADICTION TO DEVICE LABELING. A REVIEW OF DEVICE LABELING CONCLUDED THAT THE OPERATOR MANUAL ADVISES FREQUENT CLEANING OF THE TREATMENT TIP DURING USE. USER FACILITY DECLINED SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED 5MM BLISTERS TO THE INNER THIGH (2) AND KNEE (3) FOLLOWING TREATMENT WITH THE LUMENIS LIGHTSHEER ET LASER. IT WAS FURTHER REPORTED THAT THE PATIENT HAD HEALED WITH NO PERMANENT IMPAIRMENT. NO MEDICAL INTERVENTION WAS REPORTED TO PRECLUDE PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER ET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS INC. LIGHTSHEER ET

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other