BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY II

    MDR report key: 25306632 · Received May 27, 2026

    Report

    Report Number
    3021199089-2026-00037
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    CYNOSURE LUTRONIC TECHNOLOGY CORPORATION
    Product Code
    GEX
    UDI-DI
    08800291820040
    PMA / PMN Number
    K183566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CYNOSURE LUTRONIC (CL) CLINICAL TEAM CONTACTED THE SITE TO INVESTIGATE THE EVENT. CL CLINICAL CONFIRMED THAT NO INJURY HAD OCCURRED. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE TO PERFORM A DEVICE EVALUATION. FSE PERFORMED METER VERIFICATION IN ALL OPERATIVE MODES. ALL AVAILABLE WINDOWS, FIBERS, AND OPTICS ON ALL CARTRIDGES WERE INSPECTED. ICD OPERATION WAS VERIFIED. COOLANT LEVEL WAS CHECKED, AND THE AIR FILTER WAS CLEANED. BURN SAMPLES WERE RECORDED OF ALL CARTRIDGE SIZES. FULL FUNCTION TEST IN ALL OPERATIVE MODES. DEVICE CONFIRMED TO BE OPERATING WITHIN CYNOSURE LUTRONIC PUBLISHED SPECIFICATIONS. THE EVENT IS REPORTABLE PER FDA MEDICAL DEVICE REPORTING TITLE 21 CFR PART 803 SINCE AN OBSERVED MALFUNCTION OCCURRED AND COULD LIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CLARITY II TREATMENT THE CRYOGEN WAS SPRAYING CONTINUOUSLY AND RESOLVED ON ITS OWN AFTERWARDS. PROVIDER ALSO MENTIONED THAT THEY WERE NOT SEEING RESULTS WHEN PERFORMING VASCULAR TREATMENTS AND LASER WAS NOT CLEARING THE VEINS CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181617 CLARITY II CLARITY II GEX CYNOSURE LUTRONIC TECHNOLOGY CORPORATION 08800291820040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown