BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY II

    MDR report key: 25208326 · Received May 18, 2026

    Report

    Report Number
    3021199089-2026-00029
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Report Date
    May 18, 2026
    Manufacturer
    CYNOSURE LUTRONIC TECHNOLOGY CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K183566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT SITE FOR A DEVICE EVALUATION. WHEN THE FSE ARRIVED, THEY WERE INFORMED THAT WHILE USING THE INTELLITRAK, THE DEVICE INTERMITTENTLY SWITCHES FROM READY MODE TO STANDBY MODE BY ITSELF. THE DEVICE WAS SUBJECTED TO FULL FUNCTIONALITY TESTING WITH PASSING RESULTS. FSE WAS UNABLE TO DUPLICATE THE REPORTED ISSUES AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE DEVICE WAS FOUND TO BE WORKING TO PUBLISHED SPECIFICATIONS. AS A PRECAUTION THE HANDPIECE WAS REPLACED. AN INTERNAL INSPECTION OF THE HOSES AND CONNECTIONS TO ENSURE THERE WAS NO INTERNAL LEAKAGE WAS COMPLETED WITH NO DISCREPANCIES OBSERVED. ADDITIONALLY, FSE SHOWED THE CUSTOMER HOW TO PROPERLY CHANGE ICD. CYNOSURE LUTRONIC CLINICAL TEAM CONFIRMED THERE WERE NO PATIENT OR USER INJURY. THIS EVENT IS REPORTABLE UNDER FDA MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR PART 803), AS IT INVOLVES AN OBSERVED DEVICE MALFUNCTION THAT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CRYOGEN ICD ON THE CLARITY II DEVICE IS SHOOTING INTERMITTENTLY DURING TREATMENT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599615 CLARITY II CLARITY II GEX CYNOSURE LUTRONIC TECHNOLOGY CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown