BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 4193991 · Received October 22, 2014

    Report

    Report Number
    1720381-2014-00065
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    June 15, 2012
    Report Date
    October 22, 2014
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS CONTACTED THE INITIAL REPORTER AND THE THIRD PARTY VENDOR TO INVESTIGATE THE REPORTED EVENT. A REVIEW OF HISTORICAL INSTALLATION RECORDS CONFIRMED THAT LUMENIS DID NOT PROVIDE THE SUBJECT DEVICE, LIGHTSHEER DUET LASER, OR THE SUBJECT EYE SAFETY PROTECTION TO THE USER FACILITY. A REVIEW OF HISTORICAL SUBJECT DEVICE SERVICE RECORDS FOUND THAT THE USER FACILITY HELD A CONTRACTUAL SERVICE AGREEMENT WITH LUMENIS. LASER MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE EVENT REPORTED. REASONABLE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION FROM THE PATIENT'S ATTORNEY, HOWEVER NO INFORMATION WAS RECEIVED. LUMENIS CONFIRMED THROUGH A TELEPHONE CONVERSATION WITH THE THIRD-PARTY LASER VENDOR THAT THE APPROPRIATE 800 NM EYE SAFETY PROTECTION HAD BEEN PROVIDED TO THE USER FACILITY WHEN THE DEVICE WAS SOLD. A REVIEW OF SUBJECT DEVICE LABELING FOUND THE FOLLOWING INFORMATION. "ALL PERSONNEL WHO ARE WITHIN THE (B)(4) ARE CONSIDERED TO BE WITHIN THE CONTROLLED AREA AND SHALL WEAR EYE PROTECTION WITH A MINIMUM OPTICAL DENSITY (OD) OF THE FOLLOWING FOR LASER ENERGY EMITTED AT A WAVELENGTH OF 790-830NM." DESPITE REASONABLE ATTEMPTS TO OBTAIN SUFFICIENT INFORMATION WITH WHICH TO DETERMINE A ROOT CAUSE, LUMENIS IS UNABLE TO DO SO BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    AN ATTORNEY REPORTED THAT THEIR CLIENT, AN EMPLOYEE OF A HAIR REMOVAL FACILITY, "SUFFERED DAMAGE TO HER SKIN AND EYES FROM THE USE OF THE LASER WITH IMPROPER PROTECTION PROVIDED BY THE EMPLOYER." ADDITIONALLY, THE ATTORNEY REPORTED, "THE GOGGLES PROVIDED BY DEFENDANTS WERE NOT SUITED FOR THE POWER OF THE LASER OPERATED BY THE COMPANY." THE ATTORNEY REPORTED, THAT THE SUBJECT DEVICE, A LUMENIS LIGHTSHEER DUET LASER, WAS PURCHASED BY THE FACILITY THROUGH A THIRD PARTY VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671072 LIGHTSHEER DUET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX RH USA, INC. LIGHTSHEER DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 Other