BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XERF 2.0

    MDR report key: 25234689 · Received May 20, 2026

    Report

    Report Number
    3021199089-2026-00033
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 20, 2026
    Manufacturer
    CYNOSURE LUTRONIC TECHNOLOGY CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K180945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE TREATMENT CLINIC AND REQUESTED ADDITIONAL INFORMATION ABOUT THE TREATMENT TO ASSIST WITH THE INVESTIGATION INCLUDING TREATMENT PARAMETERS USED, PRE AND POST TREATMENT CARE, ANY PRE OR POST IMAGES OF THE PATIENT AS WELL AS CONFIRMATION IF THE PATIENT EXPERIENCED A BURN. ALTHOUGH THERE WERE MULTIPLE INFORMATION REQUESTS, THESE INFORMATION REQUESTS WENT UNANSWERED AND IT IS UNKNOWN IF AN INJURY OCCURRED. THE TREATMENT CLINIC PROVIDED A VIDEO OF THE REPORTED ISSUE OF CRYOGEN LEAKING FROM THE HP. IN THIS VIDEO THE CRYOGEN CAN BE OBSERVED LEAKING FROM THE HP, WHICH IS NOT NORMAL OPERATION OF THE DEVICE. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT CLINIC FOR A DEVICE EVALUATION. DURING THIS TIME THE DEVICE HP WAS REPLACED. FOLLOWING REPAIRS, THE DEVICE WAS TESTED AND FOUND TO BE WORKING TO PUBLISHED SPECIFICATIONS. SINCE THE HANDPIECE WAS LEAKING CRYOGEN, THIS IS CONSIDERED A DEVICE MALFUNCTION. THIS EVENT IS REPORTABLE UNDER FDA MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR PART 803), AS IT INVOLVES A 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 CRYOGEN WAS LEAKING OUT OF THE HANDPIECE (HP) DURING A XERF TREATMENT. TREATMENT WAS DISCONTINUED WHEN THE ISSUE OCCURRED. THE PATIENT REPORTED REDNESS ON THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473133 XERF 2.0 XERF 2.0 GEI CYNOSURE LUTRONIC TECHNOLOGY CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown