BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTHERA SYSTEM

    MDR report key: 16025772 · Received December 21, 2022

    Report

    Report Number
    3006560326-2022-00010
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    November 28, 2022
    Report Date
    January 26, 2023
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    OHV
    UDI-DI
    00840763100179
    PMA / PMN Number
    K180623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ULTHERA CONTROL UNIT AND ASSOCIATED POWER CORD WERE RETURNED TO MERZ ON 08-DEC-2022. A PRELIMINARY INVESTIGATION WAS PERFORMED BY A MERZ BIOMEDICAL ELECTRICAL ENGINEER. DURING THIS EVALUATION, NO SIGNS OF DAMAGE, ELECTRICAL DAMAGE, OR OTHER DEVIATIONS WERE OBSERVED WITH THE CONTROL UNIT NOR THE POWER CORD. THE UNIT WAS EVALUATED AND WAS FOUND TO BE IN NORMAL WORKING CONDITION. THIS CONTROL UNIT AND POWER CORD WERE THEN SUBMITTED FOR COMPLETE DIAGNOSTIC EVALUATION AND TESTING. DURING EVALUATION, THE DEVICE WAS POWERED ON/OFF SEVERAL TIMES AND TESTED BY FIRING 200 LINES WITH MULTIPLE TRANSDUCERS. NO SPARKING, EVIDENCE OF SPARKING, OR OTHER ISSUES WERE IDENTIFIED. THE DEVICE MET ALL FUNCTIONAL REQUIREMENTS AND PASSED ALL TESTING PERFORMED. BASED ON THESE FINDINGS, THE REPORTED ISSUE OF SPARKING OCCURRING AT THE CONNECTION OF THE ULTHERA CONTROL UNIT AND POWER CORD WAS NOT CONFIRMED. AN EVALUATION OF THE ORIGINAL DEVICE HISTORY RECORD (DHR) FOUND NO REWORK OR NON-CONFORMANCES WERE ASSOCIATED WITH THE MANUFACTURE OF THIS DEVICE. ALL TESTS CONDUCTED PASSED ON THE FIRST ATTEMPT. ONE DEVIATION WAS NOTED; HOWEVER, THIS DEVIATION WAS NOT RELATED AND WOULD NOT HAVE CONTRIBUTED TO THE REPORTED ISSUE. AN EVALUATION OF THE SERVICE HISTORY RECORD (SHR) FOR THIS CONTROL UNIT REVEALED THIS DEVICE HAS BEEN RETURNED FOR SERVICE ON TWO PREVIOUS OCCASIONS PRIOR TO THIS EVENT. THE REPORTED ISSUES AND SUBSEQUENT SERVICE ACTIVITIES PREVIOUSLY PERFORMED WOULD NOT HAVE CONTRIBUTED TO THIS EVENT. A REVIEW OF THE MOST RECENT ULTHERA PRODUCT COMPLAINT TRENDING ANALYSIS REVEALED THIS ISSUE HAS NOT OCCURRED AT HIGH ENOUGH FREQUENCY TO GENERATE A TREND AND WILL CONTINUE TO BE MONITORED. ALTHOUGH THE SPARKING ISSUE WAS NOT REPLICATED DURING EVALUATION AND THIS CONTROL UNIT COMPLETED SERVICING AND REPAIR, IN AN ABUNDANCE OF CAUTION THIS DEVICE WILL BE SCRAPPED TO ENSURE NO SAFETY RISK. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE ULTHERA CONTROL UNIT AND ASSOCIATED POWER CORD WERE RETURNED TO MERZ ON (B)(6) 2021. THIS CONTROL UNIT HAS BEEN SUBMITTED FOR COMPLETE DIAGNOSTIC EVALUATION AND TESTING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WHEN THE SERVICE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 0

    WHILE TROUBLESHOOTING ISSUES WITH AN ULTHERA SYSTEM FOR AN UNRELATED EVENT ON (B)(6) 2022, A CUSTOMER ALLEGED THAT SPARKS EMITTED FROM THE BACK OF THEIR CONTROL UNIT. THE USER STATED THE SPARKS ORIGINATED FROM THE AREA OF THE CONNECTION OF THE POWER CORD TO THE BACK OF THE MACHINE, AND OCCURRED WHEN THE SYSTEM WAS TURNED ON. FOLLOWING THIS EVENT, THE SYSTEM WOULD NO LONGER TURN ON. THE USER STATED THE PLUG APPEARED INTACT WITH NO SIGN OF FRAYING, AND THE POWER CORD WAS FULLY SEATED INTO THE CONTROL UNIT. THE USER WAS DIRECTED TO CEASE USE OF THIS SYSTEM IMMEDIATELY. THE PRACTICE CONFIRMED NO INJURY TO USER OR ANY PATIENTS WERE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613281 ULTHERA SYSTEM ULTHERA SYSTEM OHV MERZ NORTH AMERICA, INC. UC-1 00840763100179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other