BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 14627646 · Received June 7, 2022

    Report

    Report Number
    3011423170-2022-00073
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 9, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA LOGS WERE REVIEWED AND BASED ON THE EVALUATION OF THE DATA, THE HANDPIECE AND THE SYSTEM PERFORMED AS EXPECTED. NO ERRORS WERE RECORDED. THE PRODUCT WAS RETURNED AND THE INVESTIGATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    THE TREATMENT TIP WAS RETURNED AND THE EVALUATION WAS COMPLETED. DURING EVALUATION OF THE TREATMENT TIP, SERVICE FOUND A DIELECTRIC BREAKDOWN AROUND THE RADIO FREQUENCY TRACE. THE INVESTIGATION FOUND THAT TRACE DAMAGE FROM THE TIP MEMBRANE ARE CAUSED BY STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE THAT DAMAGED THE RADIO FREQUENCY TRACE, CAUSING ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE. THIS BURN THROUGH CAN CAUSE RISK TO THE PATIENT DURING TREATMENT. THE TIP PASSED THE FLOW TEST AND THERMISTOR TEST. THE TIP FAILED THE LEAK TEST AND VISUAL INSPECTION AS DIELECTRIC BREAKDOWN WAS OBSERVED. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE DIELECTRIC BREAKDOWN. A REVIEW OF MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. THE FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING THE THERMAGE TREATMENT, THERE WAS A SPARK THAT CAME FROM THE TIP WHEN TREATING THE UPPER LEFT CHEEK. THEY PROCEEDED TO TREAT UNDER THE CENTER OF THE PATIENT'S CHIN AND OBSERVED A SPARK COMING FROM THE TIP AGAIN. THEY STOPPED TREATMENT WITH THAT TIP. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE, BUT NOT DURING TREATMENT. NO ERROR MESSAGES WERE DISPLAYED DURING THE TREATMENT. THE PATIENT EXPERIENCE EPIDERMAL PEELING WHICH WAS TREATED WITH VISIDERM TAPE AND REPORTED THAT THERE WILL NOT BE ANY PERMANENT DAMAGE OR SCARRING. INFORMATION WAS REVIEWED BY THE MEDICAL REVIEWER AND IT WAS DETERMINED THAT A SERIOUS INJURY DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153553 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS3.00E4-900 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown