BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM TIP

    MDR report key: 14398141 · Received May 13, 2022

    Report

    Report Number
    3011423170-2022-00054
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    February 17, 2022
    Report Date
    February 20, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE THERMAGE TIP WAS RETURNED AND EVALUATED. THE TIP PASSED THE FLOW TEST AND FAILED THE LEAK TEST. THE TIP FAILED VISUAL INSPECTION AS DIALECTIC BREAKDOWN WAS OBSERVED. DUE TO START OF BURNT TRACE, NO FUNCTIONAL TESTING WAS PERFORMED. EVALUATION OF SYSTEM LOGS AND TREATMENT TIP WERE ALSO COMPLETED. 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 · 0

    THE PRODUCT EVALUATION CONFIRMED THE FAILURE MODE. SERVICE CONFIRMED THE START OF DAMAGE TO THE TIP MEMBRANE ALONG THE RADIOFREQUENCY TRACE. INVESTIGATION FOUND STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE THAT DAMAGED THE RADIOFREQUENCY TRACE, CAUSES ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE. BASED ON THE AVAILABLE INFORMATION, ERYTHEMA THAT OCCUR DURING TREATMENT WAS MOST LIKELY CAUSED BY THE START OF DAMAGE ON THE TIP MEMBRANE. THE DATALOG REVIEW INDICATED ERRORS. THE ERROR INDICATES A RECOVERABLE PROBLEM THAT REQUIRES OPERATOR INTERVENTION. IF THE ERROR OCCURS DURING A RADIOFREQUENCY TREATMENT, THE RADIOFREQUENCY DELIVERY WILL BE STOPPED, THEN A POST-COOLING STEP WILL BE COMPLETED PRIOR TO GENERATING AN ¿ERROR TONE¿ AND DISPLAYING THE EVENT CODE AND EVENT MESSAGE. AFTER THE ERROR TONE, THE SYSTEM WILL TRANSITION INTO ACTION REQUIRED MODE AND WILL DISPLAY TEXT WITH INSTRUCTIONS FOR THE OPERATOR INDICATING WHAT ACTION MAY BE REQUIRED TO RESOLVE THE ISSUE. BASED ON THE EVALUATION OF THE DATA, THE HANDPIECE AND SYSTEM FUNCTIONED AS INTENDED. DURING EVALUATION OF THE TIP, SERVICE CONFIRMED THE START OF DAMAGE ALONG THE RF TRACE. DEFECTS ON THE TIP MEMBRANE CAN LEAD TO A RAISE IN TEMPERATURE OF THE TIP DURING TREATMENT AND CAN POTENTIALLY CAUSE PATIENT BURNS. ACCORDING TO THERMAGE CPT SYSTEM TECHNICAL USER¿S MANUAL (P009240-06 REV A), ERYTHEMA/BLANCHING MAY OCCUR IN MILD FORM AND TYPICALLY RESOLVE WITHIN A FEW HOURS. HOWEVER, ON RARE OCCASIONS, ERYTHEMA HAS BEEN REPORTED TO LAST LONGER (UP TO SEVERAL WEEKS). BLANCHING USUALLY RESOLVES WITHIN TWENTY-FOUR (24) HOURS. A REVIEW OF MANUFACTURING DEVICE RECORD 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. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED ERYTHEMA ON A PATIENT'S EYELIDS DURING TREATMENT. THE PATIENT COMPLAINED OF FEELING TOO HOT DURING THE TREATMENT. THE DOCTOR REDUCED THE SETTING AND THERE WAS ERYTHEMA ON HER EYELIDS. EVEN WITH THE REDUCTION IN ENERGY DELIVERY, THE PATIENT COMPLAINED OF PAIN. THE DOCTOR STOPPED THE TREATMENT TO USE AN ICE COMPRESS AND HYDROCORTISONE CREAM ON THE BURN AREA. THEN SHE CHANGED TO A NEW TIP TO FINISH THE TREATMENT. THE REDNESS WAS ABATED BY AN ICE PACK. NO PERMANENT SCAR IS EXPECTED. THIS EVENT WAS ASSESSED BY THE MEDICAL REVIEWER AND DEEMED NOT SERIOUS. IT IS REPORTED THAT THE INCIDENT OCCURRED AT ABOUT 100 REPS INTO THE TREATMENT. THE HIGHEST ENERGY USED WAS LEVEL 1.0. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. SOLTA MEDICAL CROYGEN AND COUPLING FLUID WERE USED DURING THIS TREATMENT. THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE AND NOTHING REMARKABLE OBSERVED. THE TREATMENT TIP WAS INSPECTED AT ABOUT EVERY 50-80 REPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898920 THERMAGE CPT SYSTEM TIP ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS0.25NB1-450 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OCULAR GROWTH FACTOR GEL.