BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 11815405 · Received May 12, 2021

    Report

    Report Number
    3011423170-2021-00050
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    February 23, 2021
    Report Date
    February 25, 2021
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. A MEDICAL REVIEW OF THIS CASE DETERMINED THIS EVENT WAS NOT A SERIOUS INJURY. EVALUATION OF THE TREATMENT TIP CONFIRMED DAMAGE ALONG THE RADIO FREQUENCY TRACE OF THE TIP. INVESTIGATION FOUND DAMAGE TO THE RADIO FREQUENCY TRACE ARE CAUSED BY STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE THAT DAMAGE THE RADIO FREQUENCY TRACE, CAUSING ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE. BASED ON THE AVAILABLE INFORMATION, THIS EVENT WAS MOST LIKELY CAUSED BY DAMAGE ON THE TREATMENT TIP.

    Additional Manufacturer Narrative · 1

    THE TIP WAS RETURNED AND EVALUATED. THE EVALUATION REVEALED THAT THE TIP PASSED FLOW AND THERMISTOR TESTING. THE TIP FAILED LEAK TESTING AND VISUAL INSPECTION DUE TO BURNT TRACE OBSERVED ON THE SURFACE MEMBRANE AND THE OBSERVANCE OF DIELECTRIC BREAKDOWN ON THE TIP. NO FUNCTIONAL TESTING CAN BE PERFORMED DUE TO DIELECTRIC BREAKDOWN BEING OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORDS IS IN PROGRESS. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT WHILE PERFORMING A THERMAGE TREATMENT, A POPPING SOUND WAS HEARD AT REP 682. THE PRACTITIONER CHECKED THE TIP AFTER THE POPPING SOUND AND SAW A ¿SPARK MARK.¿ THE HIGHEST ENERGY LEVEL USED WAS 4.0 AND 3.5 WHILE TREATING THE FOREHEAD. THERE WERE SYSTEM ERRORS DURING THE TREATMENT. THE TIP WAS INSPECTED BEFORE TREATMENT AND EVERY 20-40 REPS AFTER. THE PRACTITIONER CHANGED THE TIP AND PROCEEDED WITH THE TREATMENT, WITH NO ADDITIONAL ISSUES. THE PATIENT DID EXPERIENCE A BLISTER ON THE LEFT EYEBROW. THE REVIEWED PHOTOGRAPHS SHOWED NO BLISTER OR HYPERPIGMENTED LESIONS, THERE WAS NO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710927 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL INC. TTNS3.00E4-900 222

    Patients

    Seq Age Sex Outcome Treatment
    1