BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 11897672 · Received May 27, 2021

    Report

    Report Number
    3011423170-2021-00055
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 6, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED AND EVALUATED. BURNT TRACE WAS CONFIRMED ON THE TIP SURFACE. THIS IS A VALID TIP VERIFIED AGAINST THE SOLTA DATABASE. THE TIP START TIME WAS 4:0:40 PM ON 04/28/21 AND WAS USED FOR 247 TREATMENTS. THE TIP PASSED THE FLOW TEST AND FAILED THE LEAK TEST. THE TIP FAILED THE VISUAL INSPECTION FOR BURNT TRACE ON THE TIP SURFACE. DIELECTRIC BREAKDOWN WAS OBSERVED. THE TIP PASSED THE THERMISTOR TEST. THE FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO TIP DAMAGE. THE PLANT EVALUATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    DURING THE EVALUATION OF THE TREATMENT TIP, SERVICE CONFIRMED DAMAGE OF ALONG THE RADIOFREQUENCY TRACE OF THE TIP. THIS EVALUATION CONFIRMS THE CUSTOMER¿S ACCOUNT OF ISSUES TO THE TIP MEMBRANE DURING THE TREATMENT. INVESTIGATION FOUND FLAME/SPARK FROM TIP MEMBRANE ARE CAUSED BY STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE THAT DAMAGED THE RF TRACE, CAUSING ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE. DEFECTS ON THE TIP MEMBRANE CAN LEAD TO A RAISE IN TEMPERATURE OF THE TIP AND CAN POTENTIALLY CAUSE PATIENT BURNS DURING TREATMENT. THE DATACARD WAS NOT EVALUATED SO IT IS UNCLEAR IF ANY ERRORS OCCURRED THAT ALERTED OPERATOR. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. 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). MANUFACTURING DATE: 11/16/2020.

    Description of Event or Problem · 0

    TREATMENT WAS ABLE TO BE COMPLETED WITH A DIFFERENT TIP.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS UNDERWAY AND WILL BE UPDATED AS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY STATED SHE WITNESSED A SPARK DURING TREATMENT PULSE. THERE WAS NO PATIENT CONTACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789409 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1