BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 954207 · Received April 23, 2007

    Report

    Report Number
    2914019-2002-00011
    Event Type
    Malfunction
    Date Received
    April 23, 2007
    Date of Event
    June 18, 2002
    Report Date
    April 23, 2007
    Manufacturer
    *
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REQUESTED DEVICE EVALUATION OF THE SUBJECT LIGHTSHEER DEVICE IN 2002 (ABOUT 4 WEEKS AFTER THE ALLEGED INCIDENT). THE PHYSICIAN REPORTED TO LUMENIS THAT THE LASER'S FLUENCE WAS MOVING ON ITS OWN, HOWEVER, THE PHYSICIAN DID NOT REPORT THIS POSSIBLE SAFETY INCIDENT WHEN REQUESTING THE DEVICE EVALUATION. PER THE LUMENIS SERVICE DEPOT, AT THE TIME OF THE DEVICE EVALUATION, THE TOUCHSCREEN ASSEMBLY DID NOT PASS TEST. SERVICE DEPOT REPLACED THE DISPLAY ASSEMBLY. TOUCHSCREEN PROBLEMS CAN CONTRIBUTE TO OR RESULT IN SCROLLING FLUENCE PROBLEMS. FOREIGN MATERIAL LEFT ON THE TOUCHSCREEN CAN ALSO CONTRIBUTE TO THE SCROLLING PHENOMENON, HOWEVER, THE SERVICE REPORT DOES NOT INCLUDE A FINDING OF FOREIGN MATERIAL ON THE DEVICE TOUCHSCREEN. NO FURTHER CONCLUSION CAN BE DRAWN REGARDING ANY RELATION OF THE SUBJECT LIGHTSHEER DEVICE TO THE ROOT CAUSE OF THE INCIDENT. THIS IS A LEGAL MATTER AND NO FURTHER DETAILS ARE AVAILABLE AS OF 4/23/07. BASED ON THE LIMITED INFO AVAILABLE, NO FURTHER CONCLUSION CAN BE DRAWN REGARDING ROOT CAUSE OF THE INCIDENT. IF SIGNIFICANT ADDITIONAL DETAILS ARE OBTAINED BY LUMENIS IN THE FUTURE, A FOLLOW-UP MDR REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A PT ALLEGES THAT SHE SUSTAINED SERIOUS AND PERMANENT INJURIES IN ASSOCIATION WITH LIGHTSHEER HAIR REMOVAL TREATMENT IN 2002. PER LEGAL DOCUMENTATION, THE PT SOUGHT MEDICAL TREATMENT (NO DETAILS PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) SOLID STATE AESTHETIC LASER GEX * LIGHTSHEER FT *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other