BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS, INC

    MDR report key: 1293241 · Received January 22, 2009

    Report

    Report Number
    2914019-2009-00004
    Event Type
    Injury
    Date Received
    January 22, 2009
    Date of Event
    January 8, 2009
    Report Date
    January 13, 2009
    Manufacturer
    LUMENIS, LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS FIELD SERVICE INVESTIGATION FOUND THE SUBJECT DEVICE TO BE OUT OF CALIBRATION. LUMENIS TECHNICIAN OBSERVED THE HANDPIECE TO BE OUT OF ALIGNMENT AND SYSTEM FILTER TO BE IN NEED OF CLEANING IN CONTRADICTION TO DEVICE LABELING GUIDELINES. LUMENIS HAS DETERMINED PROBABLE ROOT CAUSE TO BE IMPROPER DEVICE SELF CALIBRATION DUE TO HANDPIECE MISALIGNMENT AND GENERAL CLEANLINESS. IMPORTANCE OF DEVICE CLEANLINESS AND HANDPIECE POSITION DURING CALIBRATION IS CLEARLY EXPRESSED IN DEVICE LABELING AND PRODUCT TRAINING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A SECOND DEGREE FACIAL BURN WHILE RECEIVING IPL TREATMENT. NO MEDICAL INTERVENTION WAS REQUIRED; PATIENT HAS FULLY RECOVERED WITH NO PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS, INC LUMENIS ONE GEX LUMENIS, LTD GAL170000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R