BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAV

    MDR report key: 24471459 · Received February 27, 2026

    Report

    Report Number
    3021199089-2026-00010
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 27, 2026
    Manufacturer
    LUTRONIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08809447655277
    PMA / PMN Number
    K203788
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE FOR DEVICE EVALUATION. WHILE ON SITE, THE SYSTEM WAS IN USE DURING A TREATMENT SESSION BY THE PROVIDER. THE FSE WAS PRESENT WHILE THE TREATMENT WAS BEING PERFORMED. DURING THE TREATMENT THE FSE OBSERVED THE DEVICE MAKE A LOUD POP, SPARK AND LEAVE A BLACK SOOT MARK ON THE PATIENT. THE BLACK SOOT WAS WIPED AWAY AND THERE WAS NO VISIBLE BURN OR INJURY PRESENT. FOLLOWING THIS OBSERVATION, THE DEVICE WAS SUBJECTED TO MULTIPLE TESTS BY THE FSE INCLUDING: FULL FUNCTIONALITY CHECK, ENERGY TESTING, AND CRYOGEN TESTING ALL WITH PASSING RESULTS. THE DISTANCE GAUGE AND INTELLITRAK WERE VISUALLY INSPECTED FOR ANY EVIDENCE OF BURN MARKS OR OTHER DAMAGE WITH NO DISCREPANCIES OBSERVED. THE DEVICE WAS FOUND TO BE OPERATING WITHIN PUBLISHED SPECIFICATIONS. IT IS UNKNOWN WHAT CAUSED THE REPORTED ISSUE. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER AND DETERMINED THAT THE TREATMENT PARAMETERS USED WERE 1064 NM, 14 MM, 5 MS, 26 J, 1 HTZ,ICD 20/20/0 AND ARE WITHIN THE RECOMMENDED PUBLISHED CLINICAL GUIDELINES FOR HAIR REMOVAL TREATMENT. IT IS UNDETERMINED WHAT CAUSED THE REPORTED SPARK, POP AND BLACK SOOT ON THE PATIENTS SKIN. THE EVENT IS REPORTABLE PER FDA MEDICAL DEVICE REPORTING TITLE 21 CFR PART 803 SINCE A MALFUNCTIONED OCCURRED AND WOULD LIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DERMAV DEVICE SPARKED, MADE A LOUD POPPING SOUND AND LEFT A BLACK SOOT MARK ON THE PATIENT. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157978 DERMAV DERMAV GEX LUTRONIC CORPORATION 08809447655277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown