BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE CPT SYSTEM TIP

    MDR report key: 11979571 · Received June 10, 2021

    Report

    Report Number
    3011423170-2021-00059
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 14, 2021
    Report Date
    May 17, 2021
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H10: DIELECTRIC BREAKDOWN WAS OBSERVED. A NEW HIGH MAGNIFICATION PICTURE WAS PRODUCED THAT CHANGED THE INTERPRETATION OF THE EVALUATION. THE TIP PASSED THE FLOW TEST, THE LEAK TEST AND THE THERMISTOR TEST. THE TIP FAILED THE VISUAL INSPECTION FOR A BURNED SPOT ON THE TIP OF THE SURFACE AS DIELECTRIC BREAKDOWN WAS OBSERVED. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO E173 AND A BURN SPOT ON TIP SURFACE. THE PLANT EVALUATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    THE TREATMENT TIP AND DATACARD LOGS WERE RETURNED FOR EVALUATION. BASED ON THE EVALUATION OF THE DATACARD, THE HANDPIECE AND SYSTEM PERFORMED AS EXPECTED. DURING EVALUATION OF THE TREATMENT TIP, SERVICE FOUND DAMAGE TO THE TIP MEMBRANE. BASED ON THE AVAILABLE INFORMATION, THE HOLE IN THE TIP MEMBRANE MOST LIKELY CONTRIBUTED TO THIS EVENT. IT IS UNKNOWN WHAT CAUSED THIS DAMAGE IN THE MEMBRANE. 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 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. COMPLAINT TYPE IDENTIFIED WITHIN RISK ANALYSIS AND PERFORMING WITHIN ANTICIPATED RATE. TRENDING WILL BE PERFORMED TO MONITOR THIS ISSUE. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED AND EVALUATED. THE TIP FIRST USED AT (9:23:23 PM ON 03/15/21) AND WAS USED FOR (800) TREATMENTS. THE TIP PASSED THE FLOW TEST, THE LEAK TEST, AND THE VISUAL INSPECTION. THERE WAS NO DENTS, SCRATCHES, BLEMISHES, OR DIELECTRIC BREAKDOWN OBSERVED. THE TIP PASSED THE THERMISTOR TEST. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO EVENT CODE E173. THE DATA CARD EVALUATION REVEALED THE FOLLOWING: 1 - 76 - TIP LIFTED/TILTED DURING RF ON - 0.13%; 10 - 131 - UNDERFORCE DURING RF ON - 1.25%; 8 - 132 - UNDERFORCE DURING POST COOL - 1.00%; 8 - 133 - UNDERFORCE DURING REWARM - 1.00%. BASED ON THE EVALUATION OF THE DATA, THE HP AND SYSTEM PERFORMED AS EXPECTED. FAILURE TO MAINTAIN CONSTANT FORCE UNTIL THE TONE ENDS (UNTIL THE END OF POST COOL STATE) CAN RESULT IN AN UNSAFE CONDITION. THE SYSTEM HAS SOFTWARE SAFEGUARDS (SUCH AS A POWER ON SELF-TEST) THAT WILL TRIGGER ERROR/EVENT CODES SHOULD SYSTEM BE OUTSIDE OF ACCEPTABLE LIMITS. THE REVIEW OF THE SYSTEM/DATA LOGS DOES NOT INDICATE THERE IS ANY HANDPIECE OR SYSTEM ISSUE PRESENT. THE PLANT EVALUATION IS UNDERWAY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING A THERMAGE TREATMENT ON THE FACE, THE PATIENT EXPERIENCED WELTS. DURING THE FOLLOW-UP VISIT, THE PHYSICIAN NOTED BLISTERS/SKIN TEARS ON THE FACE AREA AND PROVIDED THE PATIENT WITH BACITRACIN OINTMENT TO BE USED 3-5 DAYS TWICE A DAY. THE PATIENT'S SKIN IS HEALING. THIS INCIDENT OCCURRED AT 300 PULSES WITH THE HIGHEST ENERGY LEVEL USED AT 3.0. NO SYSTEM ERRORS OCCURRED BUT IT WAS NOTICED THAT THIS PARTICULAR PATIENT WAS ¿WELTING¿ MORE THAN OTHER PATIENTS SHE HAD TREATED IN THE PAST. THE PHYSICIAN INSPECTED THE TREATMENT TIP AND NOTICED A SMALL HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876021 THERMAGE CPT SYSTEM TIP ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other