BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON

    MDR report key: 23057266 · Received September 15, 2025

    Report

    Report Number
    1222993-2025-00038
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    October 11, 2024
    Report Date
    September 15, 2025
    Manufacturer
    CYNOSURE LLC
    Product Code
    GEX
    PMA / PMN Number
    K142376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD CONFIRMS THAT THE PRODUCT PASSED AND MET ALL REQUIREMENTS BEFORE RELEASING. SITE CONFIRMED THAT NO PATIENTS WERE PRESENT IN THE ROOM WHEN THE INCIDENT OCCURRED. CYNOSURE FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE SITE AND INSPECTED THE UNIT. FSE REPLACED THE HVPS TO RESOLVE THE ISSUE. FSE THEN TESTED, CALIBRATED THE HANDPIECES, AND TOPPED OFF COOLANT. CYNOSURE LLC IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION SINCE IF IT WERE TO REOCCUR, THE SMOKE AND FIRE CAN CAUSE SERIOUS INJURY.

    Description of Event or Problem · 0

    SITE REPORTED THAT WHEN THEY TURNED THEIR ICON DEVICE ON FLAMES AND SMOKE CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759577 ICON ICON GEX CYNOSURE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown