BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTHERA SYSTEM

    MDR report key: 22994793 · Received September 8, 2025

    Report

    Report Number
    3006560326-2025-00005
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 8, 2025
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OHV
    UDI-DI
    00840763101145
    PMA / PMN Number
    K233996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE ULTHERA CONTROL UNIT WAS RETURNED TO MERZ FOR EVALUATION. A PRELIMINARY INVESTIGATION WAS PERFORMED BY A MERZ BIOMEDICAL ELECTRICAL ENGINEER. DURING THIS EVALUATION, A BLOWN ELECTRONIC COMPONENT (ZERO-OHM RESISTOR) ON THE POWER SUPPLY MODULE AND DEBRIS LIKELY RELATED TO THAT COMPONENT WERE IDENTIFIED. THE FAILURE OF THIS COMPONENT MAY HAVE LED TO THE REPORTED INSTANCES OF SMOKE. NO EVIDENCE OF BURNING, CHARRING, OR ARCING WERE OBSERVED AROUND OR INSIDE THE GREEN BUTTON. THE REPORTED ALLEGATION OF SPARKS COULD NOT BE CONFIRMED. THE AUDIBLE NOISE REPORTED BY THE CUSTOMER WAS FOUND TO BE THE NOISE OF THE FAN. THE FAN OPERATION IS UNAFFECTED BY THE FAILURE OF THE POWER SUPPLY, AND THIS NOISE WAS OBSERVED TO BE AT THE SAME LEVEL AS NORMAL OPERATION. THE REPORTED SYSTEM POWER ON ISSUE WAS CONFIRMED. THE CAUSE OF THE FAILURE WAS OBSERVED TO BE A FAILED POWER SUPPLY. THIS CONTROL UNIT WAS THEN SENT TO A MERZ SERVICE CENTER FOR SERVICE. DURING SERVICE, THE REPORTED ISSUES OF SPARKS, SMOKE, AND AUDIBLE NOISE WERE NOT CONFIRMED. SYSTEM POWER ON ISSUE WAS CONFIRMED. THE POWER SUPPLY WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL ISSUES WERE IDENTIFIED, AND THIS DEVICE PASSED ALL FUNCTIONAL TESTING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR UC-1 DS 2.0 CONTROL UNIT SERIAL NUMBER: (B)(6) REVEALED NO REWORK, NON-CONFORMANCES, OR DEVIATIONS WERE ASSOCIATED WITH THE MANUFACTURE OF THIS DEVICE. ALL TESTING PASSED PRIOR TO DISTRIBUTION. A REVIEW OF THE SERVICE HISTORY RECORD REVEALED THIS DEVICE HAS NOT BEEN SERVICED SINCE DISTRIBUTION. MNA-CAPA-0040 IS ONGOING TO CONSIDER THE NEED FOR ROOT CAUSE INVESTIGATION, CORRECTIVE, AND PREVENTIVE ACTION RELATED TO POWER SUPPLY ISSUES. FURTHERMORE, THIS COMPLAINT IS NOT SUBJECT TO ANY CURRENT FIELD CORRECTIVE ACTION (FCA). ULTHERA WILL MONITOR COMPLAINT DATA ACCORDING TO CURRENT STATISTICAL TREND ANALYSIS PROCEDURES. ANY STATISTICALLY VALID SIGNALS OR TRENDS WILL BE ESCALATED TO MRB REVIEW FOR CAPA CONSIDERATION. BASED ON THE INFORMATION AVAILABLE, THE REPORTED SYSTEM POWER ON ISSUE WAS CONFIRMED AS THE ZERO-OHM RESISTOR WITHIN THE POWER SUPPLY FAILED. THE ALLEGATIONS OF VISIBLE SPARKS COULD NOT BE CONFIRMED. EVALUATION DID NOT CONFIRM ANY EVIDENCE OF SMOKE OR SPARKS OCCURRING OUTSIDE OF THE DEVICE POWER SUPPLY OR FARADAY CAGE, INDICATING ALL CONTROLS FUNCTIONED AS INTENDED. IT IS NOT BELIEVED THIS DEVICE POSED A RISK OF FIRE OR HARM TO THE USER; HOWEVER, THIS REPORT WAS SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SPONTANEOUS REPORT WAS RECEIVED FROM A SALES REPRESENTATIVE ALLEGING A CONTROL UNIT STOPPED MID-OPERATION WITH SPARKS COMING FROM IT. ACCORDING TO THE TREATMENT PROVIDER, THE SPARKS CAME FROM THE GREEN BUTTON (A TINY BIT OF THEM), THEN THE SMOKE CAME OUT AROUND THE GREEN BUTTON. HE TRIED TO RESTART THE CONTROL UNIT AND HEARD A SOUND (UNABLE TO DESCRIBE), NO LIGHT, AND THE SYSTEM WOULD NOT START. NO PATIENT IMPACT WAS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441109 ULTHERA SYSTEM FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION OHV MERZ NORTH AMERICA, INC. UC-1 DS 2.0 ¿ CONTROL UNIT US 00840763101145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown