BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 7545740 · Received May 25, 2018

    Report

    Report Number
    3011423170-2018-00053
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 8, 2018
    Manufacturer
    SOLTA MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED A PATIENT EXPERIENCED A BURN ON THE CHEEK DURING THERMAGE TREATMENT. THE BURN LOOKED LIKE A SQUARE FORM. THIS OCCURRED AROUND REP 250, WITH THE HIGHEST ENERGY AT 6.0. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE, BUT NOT DURING TREATMENT. THE BURN SITE WAS COOLED BY ICE PAD AND TOPICAL STEROID WAS ADMINISTERED. THE PHYSICIAN USED AN ANESTHETIC CREAM BEFORE TREATMENT. IT WAS REPORTED BY THE CUSTOMER THAT NO SYSTEM ERRORS AND NOTHING OUT OF THE ORDINARY OCCURRED DURING TREATMENT. THE DATACARD AND TREATMENT TIP WAS RETURNED FOR EVALUATION. EVALUATION OF THE TREATMENT TIP FOUND NO ISSUES AND THE MEMBRANE WAS INTACT. THE DATACARD SHOWED THE FOLLOWING ERRORS OCCURRED DURING TREATMENT: QTY - ERROR ID ¿ DESCRIPTION - PERCENT OF REPS 1 ¿ 131 ¿ UNDERFORCE DURING RF ON ¿ 0.37% 3 ¿ 211 ¿ FORCE TOO HIGH WHEN BUTTON PUSHED ¿ 1.11% WARNING: FAILURE TO MAINTAIN CONSTANT FORCE UNTIL THE TONE ENDS (UNTIL THE END OF POST COOL STATE) CAN RESULT IN AN UNSAFE CONDITION. ERROR INDICATES A RECOVERABLE PROBLEM THAT REQUIRES OPERATOR INTERVENTION. IF THE ERROR OCCURS DURING AN RF TREATMENT, THE RF 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. ACCORDING TO THERMAGE CPT SYSTEM TECHNICAL USER¿S MANUAL (P009240-04 REV. A) BURNS, BLISTERS, SCABBING, AND SCARRING ARE KNOWN POSSIBLE PATIENT REACTION TO THERMAGE TREATMENT. 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. IN THE RARE INSTANCE OF A BURN THAT RESULTS IN A SCAR, THE SCAR WILL PROBABLY BE VERY SMALL AND RESPOND READILY TO REMOVAL WITH A LASER DEVICE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. IT WAS REPORTED BY THE CUSTOMER THAT NO SYSTEM ERRORS AND NOTHING OUT OF THE ORDINARY OCCURRED DURING TREATMENT. EVALUATION OF THE DATACARD AND TREATMENT TIP FOUND NO ISSUES AND THAT THE SYSTEM WAS WORKING WITHIN SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, BURNS, BLISTERS, SCABBING, AND SCARRING ARE KNOWN POSSIBLE ADVERSE PATIENT REACTIONS TO THERMAGE TREATMENT. TRENDING WILL BE PERFORMED TO MONITOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED: P/N#TTNS3.00C3-600. LOT#112917. S/N (B)(4). ON 12:33:11 PM ON (B)(6) 2018 TIP WAS USED FOR 269 TREATMENTS. TIP PASSED FLOW, LEAK, VISUAL (NO DENTS, SCRATCHES, BLEMISHES, DELECTRIC BREAKDOWN, OR TEARS SEEN), THERMISTOR AND FUNCTIONAL TESTING USING 50 RPS WITH NO OBSERVED ISSUES. NO DELECTRIC BREAKDOWN WAS SEEN. THE DATA LOG CARD REVEALED AN ERROR MESSAGE WARNING: FAILURE TO MAINTAIN CONSTANT FORCE UNTIL THE TONE ENDS (UNTIL THE END OF POST COOL STATE) CAN RESULT IN AN UNSAFE CONDITION. 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. FURTHER INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED DURING THERMAGE TREATMENT A PATIENT SUSTAINED A BURN ON THE CHEEK IN THE FORM A RAISED AREA IN THE SHAPE OF A SQUARE. THIS OCCURRED BEFORE OR AFTER REP 250, WITH THE HIGHEST ENERGY AT 6.0. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE, BUT NOT DURING TREATMENT. THE BURN SITE WAS COOLED BY ICE PAD AND TOPICAL STEROID WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388479 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL TTNS3.00C3-600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention