BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 7284133 · Received February 20, 2018

    Report

    Report Number
    3011423170-2018-00012
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    January 25, 2018
    Report Date
    January 23, 2018
    Manufacturer
    SOLTA MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: MANUFACTURE ADDRESS. ADDITIONAL INFORMATION: MANUFACTURE DATE. THE PATIENT WAS SEDATED USING PROPOFOL AS AN ANESTHETIC. THE TREATMENT TIP WAS NOT INSPECTED BEFORE USE. THE TREATMENT TIP AND DATACARD WERE RETURNED FOR EVALUATION. EVALUATION OF THE DATACARD FOUND THE FOLLOWING ERROR OCCURRED: QTY - ERROR ID ¿ DESCRIPTION - PERCENT OF REPS 3 ¿ 112 - RF DELIVERY EFFICIENCY ERROR (PHASE) ¿ 0.666% 2 ¿ 128 ¿ OVERFORCE DURING RF ON ¿ 0.444% 2 ¿ 132 ¿ UNDERFORCE DURING POST-COOL ¿ 0.444% 1 ¿ 133 ¿ UNDERFORCE DURING REWARM ¿ 0.222% 2 ¿ 135 ¿ HP BUTTON RELEASED DURING RF ¿ 0.444% 2 ¿ 136 - HP BUTTON RELEASED DURING POST-COOL ¿ 0.444% 1 ¿ 159 ¿TIP TEMP TOO COLD ¿ 0.222% 1 ¿ 317 - CURRENT EXCURSION ¿ 0.222% WARNING: FAILURE TO MAINTAIN CONSTANT FORCE UNTIL THE TONE ENDS (UNTIL THE END OF POST COOL STATE) CAN RESULT IN AN UNSAFE CONDITION. DURING EVALUATION OF THE TREATMENT TIP, SERVICE FOUND DAMAGE TO THE TIP MEMBRANE. 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 DIELECTRIC BREAKDOWN OF THE MEMBRANE OF THE TREATMENT TIP WHICH CONTACTS THE PATIENT DURING THE THERMAGE CPT PROCEDURE. BREAKDOWN 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. 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 DAMAGE TO MEMBRANE, 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. SOLTA ALSO REITERATES 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. 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. THERMAGE PROCEDURES HAVE BEEN PERFORMED USING SEVERAL DIFFERENT TYPES OF ANESTHESIA INCLUDING TOPICAL AND ORAL PREPARATIONS AS A MEANS OF PAIN MANAGEMENT. BASED ON CUSTOMER FEEDBACK AND INTERNAL STUDIES, SOLTA RECOMMENDS THAT PATIENT FEEDBACK REGARDING THEIR PERCEPTION OF HEAT OR DISCOMFORT DURING THE PROCEDURE IS ESSENTIAL INPUT TO GUIDE THE OPERATOR IN DETERMINING SAFE AND EFFECTIVE TREATMENT LEVELS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. BURNS, BLISTERS, SCABBING, AND SCARRING ARE ALL KNOWN POSSIBLE ADVERSE PATIENT REACTIONS TO THERMAGE TREATMENT. SOLTA RECOMMENDS THAT PATIENT FEEDBACK REGARDING THEIR PERCEPTION OF HEAT OR DISCOMFORT DURING THE PROCEDURE IS ESSENTIAL INPUT TO GUIDE THE OPERATOR IN DETERMINING SAFE AND EFFECTIVE TREATMENT LEVELS. DURING EVALUATION OF THE TREATMENT TIP, SERVICE FOUND DAMAGE TO THE TIP MEMBRANE. 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 DIELECTRIC BREAKDOWN OF THE MEMBRANE OF THE TREATMENT TIP WHICH CONTACTS THE PATIENT DURING THE THERMAGE CPT PROCEDURE. BASED ON THE AVAILABLE INFORMATION, DIELECTRIC BREAKDOWN OF THE TIP MOST LIKELY CONTRIBUTED TO THIS EVENT. UNKNOWN HOW DAMAGE TO THE TIP OCCURRED.

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED 08FEB18- P/N#TTNS0.25NB1-450. LOT#102517 .S/N# (B)(4). ON (B)(6) 2018 AT 9:25:51 PM TIP WAS USED FOR 450 TREATMENTS. TIP PASSED FLOW, LEAK, THERMISTOR TESTING. TIP FAILED VISUAL TESTING DUE TO DIELECTRIC BREAKDOWN. NO FUNCTIONAL TEST WAS PERFORMED DUE TO E234 (NO REPS REMAINING). ON (B)(6) 2018 EVALUATION OF SYSTEM LOGS AND TREATMENT TIP HAS BEEN COMPLETED. 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. THERE ARE NO FURTHER ACTIONS TO BE TAKEN.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(4) REPORTED THE PATIENT SUSTAINED A BURN ON THE UPPER AND LOWER EYE LID. THE PATIENT WAS UNDER ANESTHESIA 1 ML FENTANYL, 2 ML RQPIFEN. A 5 AMP PROPOFOL, 1 AMP 20 ML, AND AN EYE SHIELD IN PLACE. THE PATIENT ALSO HAD CPT FACE (DC1200) TREATMENT IN THE SAME AREA THE SYMPTOM OCCURRED. THE HIGHEST ENERGY LEVEL USED WAS 4-5. THE TREATMENT TIP WAS NOT INSPECTED BEFORE USE AND IT WAS NOT THE FIRST TIME USING THIS TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126979 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL TTNS0.25NB1-450

    Patients

    Seq Age Sex Outcome Treatment
    1 Other