BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 800173 · Received December 19, 2006

    Report

    Report Number
    2914019-2003-00018
    Event Type
    Other
    Date Received
    December 19, 2006
    Date of Event
    April 1, 2003
    Report Date
    December 19, 2006
    Manufacturer
    *
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: DEVICE: THE SUBJECT LIGHTSHEER DEVICE WAS EVALUATED BY THE LUMENIS SERVICE DEPOT ON 3/13/2003 FOR A COMPLAINT OF GOING INTO COOLING MODE; SERVICE DEPOT WAS NOT ABLE TO DUPLICATE THE COMPLAINT. THE SUBJECT LIGHTSHEER DEVICE WAS ALSO EVALUATED BY THE LUMENIS SERVICE DEPOT ON 7/30/2003 FOR A REPORTED P4 INTERLOCK ERROR CODE; THE SERVICE DEPOT WAS NOT ABLE TO DUPLICATE THE P4 INTERLOCK ERROR. PER LUMENIS TECHNICAL SUPPORT, THESE REPORTED PROBLEMS DO NOT RELATE TO THE SAFETY INCIDENT. BASED ON THE SERVICE HISTORY, LUMENIS BELIEVES THAT THE INCIDENT IS NOT RELATED TO THE LIGHTSHEER DEVICE. TREATMENT PARAMETERS: PER THE OPERATOR MANUAL, LUMENIS RECOMMENDS TO TEST SPOT AND ASSESS SIDE EFFECTS PRIOR TO LIGHTSHEER TREATMENT. PER THE PHYSICIAN, A TEST SPOT WAS PERFORMED ON THE NECK; THE PHYSICIAN DID NOT REPORT WHETHER TEST SPOTS WERE PERFORMED ON THE LIP AND CHIN. THE REPORTED TREATMENT PARAMETERS WERE WITHIN TOLERABLE LIMITS FOR TYPE VI SKIN (PHYSICIAN RECOMMENDED FLUENCES FOR TREATMENT WITH THE LIGHTSHEER XC DIODE LASER SYSTEM). THERE IS NO LITERATURE TO SUPPORT ANY CONNECTION BETWEEN LIGHTSHEER TREATMENT AND THE PATIENT'S ALLEGED LOSS OF SENSE OF TASTE. THERE IS ALSO NO LITERATURE TO SUPPORT THE PATIENT'S ALLEGATION THAT SHE EXPERIENCED DISCOLORATION OF THE TONGUE IN CONNECTION WITH LIGHTSHEER TREATMENT. LUMENIS HAS NO RECORD OF ANY COMPLAINTS ALLEGING LOSS OF TASTE OR DISCOLORATION OF THE TONGUE IN ASSOCIATION WITH LIGHTSHEER TREATMENT. LUMENIS CONCURS WITH THE PHYSICIAN'S OPINION THAT IF THE LIGHTSHEER OUTPUT DOES NOT PENETRATE PAST THE DERMIS, THE LIGHTSHEER TREATMENT COULD NOT HAVE AFFECTED THE PATIENT'S SENSE OF TASTE. BASED ON THE AVAILABLE DETAILS AT THIS TIME, NO OTHER CONCLUSION CAN BE DRAWN REGARDING ROOT CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO LUMENIS THAT A PATIENT WAS BLISTERED TO THE LIP AND CHIN IN CONNECTION WITH A LIGHTSHEER HAIR REMOVAL TREATMENT PERFORMED IN 2003. THE PHYSICIAN BELIEVES THAT A TOPICAL STEROID WAS PRESCRIBED AT THE TIME OF THE INCIDENT. PER THE PHYSICIAN, SHORTLY AFTER THE INCIDENT, THE PATIENT ALLEGED LOSS OF HER SENSE OF TASTE AND HAS ALSO RECENTLY ALLEGED DISCOLORATION OF THE TONGUE. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR DIABETES. AS THIS DEVICE HAS BEEN SERVICED BY LUMENIS SINCE THE ALLEGED INCIDENT, NO ADDITIONAL DEVICE EVALUATION IS INDICATED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other