BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 2395486 · Received January 3, 2012

    Report

    Report Number
    1720381-2012-00001
    Event Type
    Injury
    Date Received
    January 3, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 3, 2012
    Manufacturer
    LUMENIS INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF SUBJECT DEVICE SERVICE RECORDS CONFIRMED THE SYSTEM WAS A DEMONSTRATION UNIT THAT HAD RECENTLY HAD PREVENTATIVE MAINTENANCE COMPLETED. THE SUBJECT DEVICE WAS FOUND TO PERFORM TO MANUFACTURER'S SPECIFICATIONS. DEVICE MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE REPORTED EVENT. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED TREATMENT SETTINGS AND A PATIENT PHOTOGRAPH. THE HEALTHCARE PROFESSIONAL DETERMINED THAT THE PATIENT WAS A SKIN TYPE VI BASED ON THE PHOTOGRAPH CONCLUDING THE PATIENT WOULD LIKELY SUSTAIN A SMALL SCAR. ADDITIONALLY, THE HEALTHCARE PROFESSIONAL CONCLUDED THAT FAILURE TO COMPLETE A THOROUGH PATIENT ASSESSMENT TO DETERMINE PRIOR SUN EXPOSURE, PATIENT EXPOSURE TO DRUG-INDUCED PHOTOSENSITIVITY, AND TO DETERMINE OTHER CONDITIONS THAT WOULD BE A FACTORS IN ASSESSING THE PATIENT'S APPROPRIATENESS FOR TREATMENT TO BE THE PROBABLE CAUSE OF THE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A BURN FOLLOWING A SINGLE PULSE DURING A DEMONSTRATION OF A LUMENIS LIGHTSHEER DUET LASER. IT WAS FURTHER REPORTED THAT NO TEST PATCH OR PATIENT ASSESSMENT WAS COMPLETED PRIOR TO THE DEMONSTRATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other