BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 4962096 · Received August 3, 2015

    Report

    Report Number
    1720381-2015-00042
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    April 12, 2015
    Report Date
    August 3, 2015
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENTS OBTAINING PATIENT INFORMATION, TREATMENT SETTINGS, PATIENT PHOTOGRAPHS AND SUBJECT DEVICE IDENTIFIER INFORMATION FROM THE DISTRIBUTOR. ADDITIONALLY, THE DISTRIBUTOR PROVIDED HISTORICAL SERVICE RECORDS FOR THE SUBJECT DEVICE. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS-TRAINED TECHNICAL SPECIALIST CONCLUDED THE DEVICE OPERATED TO MANUFACTURE SPECIFICATIONS. THE TECHNICAL SPECIALIST NOTED THAT DEBRIS BUILD UP WAS OBSERVED ON THE TREATMENT TIP AND CALIBRATION PORT AS A RESULT OF INSUFFICIENT CLEANING BY THE DEVICE OPERATOR IN CONTRADICTION TO DEVICE LABELING AND COMMON MEDICAL PRACTICE. ADDITIONALLY, THE SPECIALIST STATED "TREATMENTS WERE DONE WITH A HIGHER THAN NORMAL ENERGY OUTPUT DUE TO IMPROPER CALIBRATION WITH DIRTY TIP AND CALIBRATION PORT." SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE EVENT REPORTED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENTS DETAILS AND PATIENT PHOTOGRAPHS CONCLUDING THE REPORTED TREATMENT SETTINGS WERE AGGRESSIVE 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 AND CALIBRATION PORT 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 ET 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

    IT WAS REPORTED BY A FOREIGN DISTRIBUTOR THAT THREE (3) PATIENTS SUSTAINED FIRST DEGREE BURNS TO THE LEG, BIKINI AND ARM AREAS RESPECTIVELY FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER DUET LASER, ET HANDPIECE. 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
    504618 LIGHTSHEER DUET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX RH USA, INC. LIGHTSHEER DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 Other