BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 7966819 · Received October 15, 2018

    Report

    Report Number
    3011423170-2018-00102
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 21, 2018
    Report Date
    October 4, 2018
    Manufacturer
    SOLTA MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR SERIAL/LOT NUMBER (B)(4), MANUFACTURING DATE: 05/30/2018. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. ON 03OCT2018, EVALUATION OF THE DATA LOGS CONCLUDED THAT THE HANDPIECE AND SYSTEM PERFORMED AS EXPECTED. 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. SEVERAL ERROR MESSAGES WERE RECEIVED, INCLUDING OVERFORCE, UNDERFORCE, AND TIP LIFTED/TILTED ERRORS. SOLTA EMPHASIZES THE IMPORTANCE OF CLINICIAN ATTENTION TO TREATMENT ERROR MESSAGES PROVIDED BY THE SYSTEM, IN PARTICULAR MESSAGES INDICATING UNDERFORCE AND LIFTING IRREGULARITIES. AS WITH ALL THERMAGE SYSTEMS, ENSURING PERPENDICULAR CONTACT BETWEEN THE HANDPIECE AND SKIN IS CRITICAL. ON 04OCT2018 TREATMENT TIP P/N#TTNS3.00E4-1200 LOT#053018 .S/N# (B)(4) WAS EVALUATED. THE TIP PASSED FLOW TESTING; HOWEVER, THE TIP FAILED LEAK, VISUAL, AND THERMISTOR TESTING. VISUAL TESTING FAILED DUE TO THE OBSERVATION OF DIELECTRIC BREAKDOWN, AND AS SUCH NO FUNCTIONAL TESTING COULD BE PERFORMED. SOLTA MEDICAL HAS CONFIRMED A LOW INCIDENCE (LESS THAN 1% OF THE TOTAL ESTIMATED NUMBER OF TREATMENTS) OF FIRST- AND SECOND-DEGREE PATIENT BURNS ASSOCIATED WITH BREAKDOWN OF THE DIELECTRIC MEMBRANE OF THE TREATMENT TIP WHICH CONTACTS THE PATIENT DURING THE THERMAGE CPT PROCEDURE. BREAKDOWN OF THE DIELECTRIC MATERIAL, AND/OR BUILD-UP OF FOREIGN SUBSTANCE ON THE DIELECTRIC, 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. BOTH THE THERMAGE USER MANUAL (P009240-04 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. IN ADDITION TO RECOMMENDING FREQUENT TIP MEMBRANE INSPECTION, SOLTA EMPHASIZES ITS RECOMMENDATION TO CAREFULLY MONITOR THE CONDITION OF THE PATIENT¿S SKIN DURING TREATMENT. IN THE CASE OF A DIELECTRIC BREAKDOWN, THE CLINICIAN MAY NOTICE THE ONSET OF SMALL BURNS WHICH WOULD BE EVIDENCED BY SMALL RESIDUAL FOCAL RED MARKS OR WHITE SPOTS. SHOULD THIS OCCUR, IT IS UP TO THE CLINICIAN¿S PROFESSIONAL DISCRETION TO DETERMINE WHETHER TO CONTINUE TREATMENT AFTER REPLACEMENT OF THE COMPROMISED TIP. BURNS, BLISTERS, SCABBING, AND SCARRING ARE ALL KNOWN POSSIBLE ADVERSE PATIENT REACTIONS TO THERMAGE TREATMENT. THERMAGE SYSTEM TECHNICAL USER¿S MANUAL (P009240-04 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. BASED ON THE AVAILABLE INFORMATION, DIELECTRIC BREAKDOWN OF THE TIP MOST LIKELY CONTRIBUTED TO THIS EVENT. NO DEFINITIVE ROOT CAUSE CAN BE IDENTIFIED FOR THE DIELECTRIC BREAKDOWN. THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A USER FACILITY IN (B)(6) REPORTED THAT ON (B)(6) 2018 A PATIENT EXPERIENCED BURNS ON THE FOREHEAD AFTER A THERMAGE TREATMENT. TOPICAL OINTMENT WAS APPLIED. THE REPS AND ENERGY LEVEL INFORMATION ARE NOT AVAILABLE. NOTHING OUT OF THE ORDINARY WAS OBSERVED DURING THE TREATMENT. THE TIP WAS INSPECTED PRIOR TO USE AND EVERY 50 PULSES DURING TREATMENT WITH NO ABNORMALITIES OBSERVED. THIS WAS THE FIRST USE OF THE TREATMENT TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807025 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL TTNS3.00E4-1200

    Patients

    Seq Age Sex Outcome Treatment
    1