BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 3761155 · Received April 21, 2014

    Report

    Report Number
    3004135191-2014-00028
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 20, 2014
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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, WHICH WERE PROVIDED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED TO MANUFACTURER SPECIFICATIONS. FURTHERMORE; THE EXPERT STATED "UPON EVALUATION NOTED BLACK SMUDGE ON THE ET CRYSTAL." NO DEVICE MALFUNCTION WAS OBSERVED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS AND PATIENT PHOTOGRAPH CONCLUDING THE REPORTED TREATMENT SETTINGS WERE APPROPRIATE BASED ON COMMON MEDICAL PRACTICE AND DEVICE LABELING. FURTHERMORE; THE PROFESSIONAL CONCLUDED THE PROBABLE ROOT CAUSE TO BE DEBRIS BUILD UP ON THE TREATMENT TIP AS A RESULT OF INSUFFICIENT CLEANING BY THE USER FACILITY IN CONTRADICTION TO DEVICE LABELING. A REVIEW OF SUBJECT DEVICE LABELING FOUND THE FOLLOWING PRECAUTIONARY STATEMENTS: "WARNING - THE SAPPHIRE TIP OF THE HANDPIECE MUST BE KEPT CLEAN DURING PATIENT TREATMENT. FOREIGN MATTER ON THE TIP WILL GET HOT DUE TO ABSORPTION OF LASER LIGHT AND CAN CAUSE EPIDERMAL INJURY AND SUBSTANTIALLY INCREASED PAIN."

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THREE (3) PATIENTS SUSTAINED FIRST DEGREE BURNS TO THE BIKINI, ABDOMEN AND UNDERARM AREA'S RESPECTIVELY FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER DUET LASER ET HANDPIECE. IT WAS FURTHER REPORTED THAT THE PATIENTS HAD HEALED. NO INFORMATION REGARDING A REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240492 LIGHTSHEER DUET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS, LTD. LIGHTSHEER DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 Other