BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY II

    MDR report key: 25234642 · Received May 20, 2026

    Report

    Report Number
    3021199089-2026-00030
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 20, 2026
    Manufacturer
    CYNOSURE LUTRONIC TECHNOLOGY CORPORATION
    Product Code
    GEX
    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

    A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE FOR A DEVICE EVALUATION. DURING THIS TIME THE DEVICE, THE DEVICE HP AND DEVICE FOOT PEDAL WERE ALL SUBJECTED TO FULL FUNCTIONALITY TESTING AND VISUAL INSPECTION WITH PASSING RESULTS. THE REPORTED ISSUE OF DEVICE MISFIRING WAS UNABLE TO BE DUPLICATED. HOWEVER, DAMAGE OBSERVED TO THE LASER SHOWS EVIDENCE THAT THE DEVICE MISFIRED WAS NOTED. THE DAMAGE IS CONSISTENT WITH THE HP NOT BEING PLACED IN THE HP HOLSTER CORRECTLY CAUSING THE HP BUTTON TO BE ENGAGED AND THE HP TO FIRE. TO CORRECT THIS DAMAGE, THE CARTRIDGE CASE WAS REPLACED AND THE FSE DISCUSSED PROPER HP PLACEMENT WITH THE CUSTOMER TO REDUCE THE PROBABILITY OF REOCCURRENCE. IT IS UNDETERMINED WHAT CAUSED THE REPORTED MISFIRING. TO REDUCE THE PROBABILITY OF RECURRENCE THE CLINICAL TEAM REVIEWED WITH THE TREATMENT PROVIDER SAFE PRACTICES, INCLUDING PUTTING THE DEVICE ON STANDBY BEFORE PUTTING THE HANDPIECE IN THE CRADLE TO PREVENT MISFIRING. SINCE A REPORTED MALFUNCTION OCCURRED AND THERE IS POTENTIAL SERIOUS INJURY, WE ARE REPORTING THIS AS AN ARO EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLARITY II DEVICE HANDPIECE WAS IN THE HOLSTER AND NOT IN USE WHEN IT FIRED ON ITS OWN. THE HANDPIECE (HP) CARTRIDGE CASE WAS DAMAGED DUE TO THE MISFIRE. CLINICAL CONFIRMED THERE WERE NO INJURIES REPORTED TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393304 CLARITY II CLARITY II GEX CYNOSURE LUTRONIC TECHNOLOGY CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown