BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE TIP

    MDR report key: 7316639 · Received March 6, 2018

    Report

    Report Number
    3011423170-2018-00018
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    February 2, 2018
    Report Date
    February 4, 2018
    Manufacturer
    SOLTA MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING EVALUATION OF THE TREATMENT TIP, PRODUCT SUPPORT 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 TEARS/CUTS 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. MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. NO HARM TO THE PATIENT WAS INDICATED. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED ON HOW HOLE ON TIP OCCURRED.

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETE: P/N# (B)(4) WITH LOT#061517 AND S/N# (B)(4) WAS RECEIVED. THE TIP WAS USED FOR 459 TREATMENTS. THE TIP PASSED FLOW AND THERMISTOR TESTING. NO LEAK TEST WAS PERFORMED. TIP FAILED VISUAL TEST DUE TO DIELECTRIC BREAKDOWN BEING PRESENT. NO FUNCTIONAL TEST WAS PERFORMED DUE TO DIELECTRIC BREAKDOWN BEING SEEN.

    Description of Event or Problem · 1

    NEAR THE END OF THE 500 PULSE LIMIT THE OPERATOR INSPECTED THE TIP MEMBRANE AND NOTICED A HOLE. THERE WERE NO ADVERSE EVENT CONDITIONS NOTED BY THE OPERATOR. THEY REPLACED THE TIP AND CONTINUED THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159851 THERMAGE TIP ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL TTNS16.00E2-500

    Patients

    Seq Age Sex Outcome Treatment
    1