BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY II

    MDR report key: 23198809 · Received October 2, 2025

    Report

    Report Number
    1222993-2025-00046
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Report Date
    December 10, 2025
    Manufacturer
    LUTRONIC CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP REPORT TO MEDWATCH 1222993-2025-00046 DUE TO DEVICE INVESTIGATION COMPLETED. CRYOGEN IS APPLIED TO THE TREATMENT SITE DURING VASCULAR TREATMENT TO PRECOOL THE SKIN. THE CRYOGEN BEGINS TO VAPORIZE FROM THE SURFACE OF THE SKIN SHORTLY AFTER CONTACT. THE LASER FIRES ONTO THE SURFACE OF THE SKIN AFTER A DELAY TIME. THE SPARK/IGNITION EVENTS OCCUR WHEN RESIDUAL CRYOGEN VAPORS REMAINING ON THE SKIN SURFACE INTERACT WITH THE HIGH-ENERGY 1064 NM LASER FLUENCE. LONGER PRE-COOLING AND DELAY TIMES INCREASE THE LIKELIHOOD OF UNEVEN VAPOR ACCUMULATION, THEREBY ELEVATING THE RISK OF IGNITION. THIS CAN BE OBSERVED AS A SPARK AND CAN RESULT IN TOPICAL BURN.

    Description of Event or Problem · 0

    A SECOND INCIDENT OCCURRED WHEN AN UNUSUAL SPARK LEFT A SMALL RESIDUE ON ANOTHER PATIENT'S NOSE DURING A CLARITY II TREATMENT USING 3MM SPOT SIZE WITH I TYPE TIP. IT WAS NOTED THAT PATIENT'S SKIN WAS PROPERLY PREPPED PRIOR TO TREATMENT, AND THERE WERE NO OBSTRUCTIONS OR EXTERNAL FACTORS IN THE LASER PATH THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE RESIDUE WAS LIMITED TO THE TREATMENT TIP AREA, AND NO VISIBLE CHANGES, BURNS, OR ADVERSE EFFECTS WERE NOTED ON THE CLIENT'S SKIN. SITE SHARED PHOTO OF BLACK RESIDUE BEFORE IT WAS WIPED, AND A PHOTO OF IT AFTER IT WAS WIPED. NO SKIN CHANGES OR ISSUES WERE OBSERVED IN THE AFTER PHOTO. ON (B)(6) 2025, SITE CALLED BACK TO RELAY ISSUE WAS STILL OCCURRING. A CYNOSURE CLINICAL TRAINER WAS ALSO THERE AND EXPERIENCED THE SAME ISSUE. FIRST EVENT WAS REPORTED AS 1222993-2025-00045. A CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE FOR DEVICE EVALUATION. THE DEVICE WAS SUBJECTED TO MULTIPLE TESTS WITH RESULTS CONFIRMING IT WAS WITHIN MANUFACTURER SPECIFICATIONS. FSE REPLICATED TREATMENT PARAMETERS AND NO IRREGULARITIES DETECTED DURING TESTING. NO ABNORMALITIES WERE FOUND WITH TREATMENT TIP, OPTICS, OR HANDPIECE. AT THIS TIME, IT IS UNKNOWN WHAT CONTRIBUTED TO THE REPORTED MALFUNCTION. ALTHOUGH THE DEVICE WAS FOUND TO BE OPERATING AS EXPECTED THE INVESTIGATION TO IDENTIFY ROOT CAUSE TO DETERMINE IF A TRUE DEVICE MALFUNCTION OCCURRED IS STILL ONGOING. A FINAL MDR WILL BE SUBMITTED ONCE FURTHER INVESTIGATION HAS BEEN COMPLETED. SINCE A REPORTED MALFUNCTION OCCURRED AND THERE IS POTENTIAL SERIOUS INJURY, WE ARE REPORTING THIS AS AN INITIAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426728 CLARITY II CLARITY II GEX LUTRONIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown