BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 11838131 · Received May 17, 2021

    Report

    Report Number
    3011423170-2021-00052
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 20, 2021
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE TREATMENT TIP CONFIRMED DAMAGE ALONG THE RADIOFREQUENCY TRACE OF THE TIP. THE INVESTIGATION FOUND DAMAGE TO THE RADIOFREQUENCY TRACE ARE CAUSED BY STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE THAT DAMAGE THE RADIOFREQUENCY TRACE, CAUSING ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE. DEFECTS ON THE TIP MEMBRANE CAN CAUSE THE RADIOFREQUENCY ENERGY, DELIVERED BY THE SYSTEM, TO FOCUS IN A SMALL AREA OF THE MEMBRANE, RATHER THAN TO BE UNIFORMLY DISTRIBUTED OVER THE ENTIRE MEMBRANE AREA AND CAN POTENTIALLY CAUSE PATIENT BURNS. THIS CAN ALSO CAUSE SPARKING FROM THE TIP DURING TREATMENT CONFIRMING CUSTOMERS REPORT OF SPARKING DURING TREATMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR SERIAL/LOT NUMBER (B)(6). A CAPA WAS OPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND EVALUATED. A BURNT TRACE ON THE TIP MEMBRANE WAS CONFIRMED. THE TIP PASSED FLOW AND FAILED LEAK TESTS. THE TIP FAILED VISUAL INSPECTION FOR BURNT TRACE ON TIP SURFACE. DIELECTRIC BREAKDOWN WAS OBSERVED. THE TIP PASSED THERMISTOR TEST. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO DAMAGE ON THE TIP SURFACE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE WAS A SPARK FROM THE TIP MEMBRANE. THIS WAS WITNESSED DURING THE TREATMENT PULSE. THE PULSES WERE PREVIOUSLY COMPLETED. THE USER ALSO STATED THAT SHE DIDN'T SEE ANY ABNORMAL PHYSICAL CONDITIONS ON THE SKIN WHERE SPARK OCCURRED AT END OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728832 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1