BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER ET

    MDR report key: 2220685 · Received August 23, 2011

    Report

    Report Number
    1720381-2011-00044
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 23, 2011
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS WERE MADE TO OBTAIN DETAILED INFORMATION ABOUT THE EVENT REPORTED INCLUDING PATIENT PHOTOS AND TREATMENT SETTINGS; HOWEVER, NO INFORMATION WAS PROVIDED. THEREFORE NO EVALUATION OF THE APPROPRIATENESS OF TREATMENT SETTINGS COULD BE COMPLETED. A REVIEW OF SERVICE RECORDS FOR THE SUBJECT DEVICE FOUND THAT THE USER FACILITY DID NOT HAVE A SERVICE CONTRACT AND THAT THE SYSTEM HAD LAST HAD PREVENTATIVE MAINTENANCE COMPLETED IN 2008. A REVIEW OF DEVICE LABELING FOUND THAT ANNUAL PREVENTATIVE MAINTENANCE IS REQUIRED TO MAINTAIN THE DEVICE TO MANUFACTURED SPECIFICATIONS. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST CONCLUDED THAT THE SUBJECT DEVICE HANDPIECE HAD NOT BEEN REPLACED BY THE FACILITY SINCE 2008. THE HANDPIECE IS A CONSUMABLE ACCESSORY. AN EVALUATION OF THE EVENT DETAILS CONCLUDED THE ROOT CAUSE OF THE EVENT REPORTED TO BE FAILURE ON THE PART OF THE DEVICE OPERATOR TO MAINTAIN THE DEVICE TO FUNCTIONAL SPECIFICATIONS BY HAVING THE SYSTEM PERFORMANCE EVALUATED DURING RECOMMENDED SERVICE INTERVALS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED BURNS TO THE FACE DURING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER ET LASER AT A FACILITY IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER ET INTENSE PULSE LIGHT DELIVERY DEVICE: DIODE GEX LUMENIS, INC. ET

    Patients

    Seq Age Sex Outcome Treatment
    1 Other