BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DESIRE

    MDR report key: 23333910 · Received October 19, 2025

    Report

    Report Number
    3021349626-2025-00009
    Event Type
    Injury
    Date Received
    October 19, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 19, 2025
    Manufacturer
    LUMENIS BE LTD
    Product Code
    GEX
    UDI-DI
    07290109140384
    PMA / PMN Number
    K170179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION AND PATIENT PHOTO. NO INCIDENT FORM OR PATIENT PHOTO HAS BEEN RECEIVED IN LUMENIS. THE DEVICE WAS INSTALLED ON (B)(6) 2015 AND LAST PM WAS ON (B)(6) 2025. AN EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED BY LUMENIS SERVICE ENGINEER AFTER VERIFYING ALL SYSTEM FUNCTIONS INCLUDING OUTPUT ENERGY VERIFICATION, FOUND ALL POWER PARAMETERS WITHIN LUMENIS SPECIFICATIONS. NO DEVICE MALFUNCTION WAS OBSERVED. THE SYSTEM WAS OPERATIONAL AND WAS READY FOR USE. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. CLINICAL EVALUATION WASN'T PERFORMED, SINCE NO INCIDENT FORM OR PHOTOS WERE SENT TO LUMENIS. WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT A SERIOUS INJURY NOR MALFUNCTION HAD OCCURRED, BECAUSE OF THE LACK OF INFORMATION LUMENIS IS REPORTING THE EVENT IN AN 'ABUNDANCE OF CAUTION'. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. LUMENIS IS CLOSING THIS COMPLAINT BUT WILL CONTINUE TO MONITOR THIS FAILURE MODE; COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP (DOC NO. (B)(4) AND PER POST MARKETING SURVEILLANCE PROCEDURE (DOC NO. (B)(4).

    Description of Event or Problem · 0

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED BURNS USING HS HANDPIECE FOLLOWING TREATMENT BY LIGHTSHEER DESIRE DEVICE. SINCE NO INCIDENT FORM RECEIVED IN LUMENIS, THIS COMPLAINT WILL REPRESENT ALL INJURED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617793 LIGHTSHEER DESIRE SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS BE LTD LIGHTSHEER DESIRE 07290109140384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other