BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XERF 2.0

    MDR report key: 25236741 · Received May 20, 2026

    Report

    Report Number
    3021199089-2026-00034
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER PAID A VISIT TO THE TREATMENT FACILITY FOR A DEVICE EVALUATION. DURING THIS TIME THE DEVICE WAS INSPECTED, AND THERE WAS NO APPARENT DAMAGE TO THE DEVICE. THE DEVICE WAS ALSO SUBJECTED TO FULL FUNCTIONALITY TESTING WITH PASSING RESULTS. THE ENERGY LEVELS AND SETTINGS WERE CHECKED AND VERIFIED TO BE WORKING WITHIN SPECIFICATIONS. IT IS UNDETERMINED THE EXACT ROOT CAUSE OF THIS INCIDENT. ADDITIONALLY, THE HANDPIECE WAS ALSO EVALUATED AND FOUND TO BE WORKING WITHIN ITS SPECIFICATIONS. AS A PRECAUTION, THE O-RING WAS REPLACED, AND THE DEVICE WAS CONCLUDED TO BE WORKING WITHIN ITS SPECIFICATIONS. THE FSE ALSO REPLACED THE DAMAGED EFFECTOR TIP WHICH WILL BE SHIPPED TO THE MANUFACTURER FOR FURTHER EVALUATION AND INVESTIGATION. THE CAUSE OF THE DAMAGE OBSERVED TO THE TIP CANNOT BE DETERMINED AT THIS TIME. ROOT CAUSE WILL BE DETERMINED AFTER THE TIP HAS BEEN RECEIVED AND EVALUATED BY THE MANUFACTURER. THE CYNOSURE LUTRONIC CLINICAL TEAM FOLLOWED UP WITH THE TREATMENT CLINIC AND IT WAS REPORTED THAT THE PATIENT VISITED A DERMATOLOGIST. THE PATIENT REPORTED THAT THE DERMATOLOGIST STATED THAT THEY BELIEVE THIS COULD BE A REACTION TO EXCESSIVE HEAT WHICH CAUSED BLISTERING THEN OOZING AND NOW DERMATITIS. PA PUT HER ON AN ORAL ANTIBIOTIC AND TOPICAL STEROID. DERMATOLOGIST GAVE HER A STEROID INJECTION. SWABBED BLISTERS AND ARE TESTING TO SEE IF THERE IS ANY BACTERIAL OR VIRAL INFECTION THE CYNOSURE LUTRONIC MEDICAL DIRECTOR REVIEWED IMAGES FROM THIS CASE SENT ON 4/20/2026 AND 4/29/2026. THE MEDICAL DIRECTOR STATED THAT THE IMAGES REVIEWED FROM 4/29/2026 APPEAR TO BE DRY SCABS FOLLOWING EITHER PARTIAL OR FULL THICKNESS BURNS, HOWEVER, DUE TO THE SIZE AND THE IMAGES IT WAS UNABLE TO BE DETERMINED WHICH. THERE WAS NO INDICATION OF INFECTION. THE MEDICAL DIRECTOR RECOMMENDED THAT THE PATIENT BE SEEN BY A PLASTIC SURGEON OR DERMATOLOGIST FOR PROPER CARE. THE MEDICAL RECOMMENDED THAT THE AFFECTED AREAS BE CLEANED TWICE A DAY WITH H A GENTLE CLEANSER AND KEPT MOIST WITH A THIN LAYER OF AQUAPHOR OR VANI CREAM. ADDITIONALLY, IT WAS STATED THAT IF THERE WERE FULL THICKNESS BURNS PRESENT, IT WAS LIKELY THERE WOULD BE A SCAR. 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 DURING TREATMENT WITH A XERF 2.0 DEVICE, THE PATIENT EXPERIENCED SEVERAL BURN SPOTS ON THE FACE. IT WAS ALSO OBSERVED THAT THE EFFECTOR 60 TIP HAD A CIRCULAR SCORCHED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38449 XERF 2.0 XERF 2.0 GEI CYNOSURE LUTRONIC TECHNOLOGY CORPORATION 1101300330

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other