BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM TIP

    MDR report key: 12737756 · Received November 2, 2021

    Report

    Report Number
    3011423170-2021-00122
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Report Date
    August 13, 2021
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA LOGS WERE REVIEWED AND BASED ON THE EVALUATION OF THE DATA, THE HANDPIECE AND SYSTEM PERFORMED AS EXPECTED. EVALUATION OF THE DATA CARD LOGS SHOWED ERRORS OCCURRED DURING TREATMENT. FAILURE TO MAINTAIN CONSTANT FORCE UNTIL THE TONE ENDS (UNTIL THE END OF POST COOL STATE) CAN RESULT IN AN UNSAFE CONDITION. PRESS ACTIVATION SWITCH BEFORE MAKING CONTACT WITH SKIN. ERRORS INDICATE 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. DURING EVALUATION OF THE TREATMENT TIP, SERVICE CONFIRMED DAMAGE ON THE TIP MEMBRANE ALONG THE RADIOFREQUENCY TRACE. SOLTA MEDICAL HAS CONFIRMED A LOW INCIDENCE (LESS THAN 1% OF THE TOTAL ESTIMATED NUMBER OF TREATMENTS) OF FIRST DEGREE PATIENT BURNS ASSOCIATED WITH RADIOFREQUENCY TRACE DAMAGE OF THE TREATMENT TIP WHICH CONTACTS THE PATIENT DURING THE THERMAGE CPT PROCEDURE. DAMAGE OF THE 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. DAMAGE TO THE RADIOFREQUENCY CAN ALSO LEAD TO REPORTS OR OBSERVATIONS OF SPARKING DURING TREATMENT. A MEDICAL REVIEW OF THIS CASE DETERMINED THIS EVENT WAS NOT SERIOUS. BOTH THE THERMAGE USER MANUAL (P009240-06 REV. A) AND TECHNICAL BULLETIN TB-19 INSTRUCTS THE OPERATOR TO INSPECT THE TREATMENT TIPS FOR ANY SIGNS OF PHYSICAL DAMAGE PRIOR, DURING, AND AFTER TREATMENT. WITH RESPECT TO ALL THERMAGE SYSTEMS CLINICIANS SHOULD FREQUENTLY INSPECT THE TIP MEMBRANE DURING TREATMENT FOR SIGNS OF BREAKDOWN AND BUILD-UP OF FOREIGN SUBSTANCES. WITH RESPECT TO THE CPT SYSTEM, SOLTA RECOMMENDS THAT A TIP MEMBRANE INSPECTION BE PERFORMED AT THE OUTSET OF THE PROCEDURE AND EVERY 50 (FIFTY) PULSES THEREAFTER. BURNS, BLISTERS, AND SCABBING ARE ALL KNOWN POSSIBLE ADVERSE PATIENT REACTIONS TO THERMAGE TREATMENT. THERMAGE SYSTEM TECHNICAL USER¿S MANUAL (P009240-06 REV. A) STATES THE PROCEDURE MAY PRODUCE HEATING IN THE UPPER LAYERS OF THE SKIN, CAUSING BURNS AND SUBSEQUENT BLISTER AND SCAB FORMATION. THERE IS A SMALL CHANCE OF SCAR FORMATION. APPLICATION OF TOPICAL STEROIDAL OR ANTIBIOTIC PREPARATIONS MAY BE OF BENEFIT. 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. NO CORRECTIVE ACTION REQUIRED. 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).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND EVALUATED AND WAS DETERMINED THAT THERE WAS NO DIELECTRIC BREAKDOWN. HOWEVER, THE EVALUATION WAS REVISED ON (B)(6) 2021 AND FURTHER EVALUATED WHICH DID CONFIRM THAT DIELECTRIC BREAKDOWN WAS PRESENT. THE TIP PASSED FLOW TEST AND FAILED THE LEAK TEST. THE TIP FAILED THE VISUAL INSPECTION AS BURNT TRACE WAS FOUND AND DIELECTRIC BREAKDOWN WAS OBSERVED. THE TIP PASSED THE THERMISTOR TEST. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE BURN ON THE TIP. BASED ON THE EVALUATION OF THE DATA, THE HANDPIECE AND SYSTEM PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED A BURN ON THE PATIENT'S RIGHT CHEEK. A SPARK WAS ALSO SEEN BY THE CLINICIAN AT THE THERMAGE TREATMENT TIP WHICH OCCURRED AT APPROXIMATELY 1050 RANGE OF REPS. THE PATIENT'S CURRENT STATUS IS REPORTED AS STABLE AND ARE UNSURE IF THERE BE ANY PERMANENT DAMAGE OR SCARRING. AN AVAILABLE PICTURE WAS REVIEWED AND A SMALL CRUSTED LESION IS VISIBLE ON THE CHEEK. THE BLISTER IS RECOVERING. NO OTHER TREATMENTS (BESIDES THERMAGE) WERE BEING PERFORMED IN SAME AREA WHERE THE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 30 DAYS. THE TREATMENT TIP SURFACE WAS INSPECTED PRIOR TO USE AND NOTHING UNUSUAL WAS NOTED. THE TREATMENT TIP SURFACE WAS INSPECTED DURING THE TREATMENT AT EVERY 150 PULSES. THIS IS THE FIRST TIME THE TREATMENT TIP WAS USED. THE HIGHEST ENERGY LEVEL USED WAS A 2. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638760 THERMAGE CPT SYSTEM TIP ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other