BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 11851218 · Received May 19, 2021

    Report

    Report Number
    3011423170-2021-00053
    Event Type
    Malfunction
    Date Received
    May 19, 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
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE EVALUATION OF THE TREATMENT TIP, RADIO FREQUENCY TRACE DAMAGE WAS NOTICED DURING VISUAL INSPECTION. DEFECTS ON THE TIP MEMBRANE CAN LEAD TO A RISE IN TEMPERATURE OF THE TIP DURING TREATMENT AND CAN POTENTIALLY CAUSE PATIENT BURNS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED THAT ALL REQUIREMENTS WERE MET. NO PATIENT INJURY OCCURRED DURING THE TREATMENT. INVESTIGATION FOUND RADIO FREQUENCY TRACE DAMAGE ARE CAUSED BY STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE THAT DAMAGED THE RADIO FREQUENCY TRACE, CAUSING ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE.

    Description of Event or Problem · 0

    THE ERROR DISPLAYED AT 746 REPS.

    Additional Manufacturer Narrative · 1

    THE TIP WAS RETURNED AND EVALUATED. THE EVALUATION REVEALED THAT THE TIP PASSED FLOW AND THERMISTOR TESTING. IT FAILED LEAK TESTING AND VISUAL INSPECTION DUE TO THE OBSERVANCE OF DIELECTRIC BREAKDOWN ON THE TIP. NO FUNCTIONAL TESTING COULD 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 CLINIC REPORTED THAT WHILE PERFORMING A THERMAGE TREATMENT, A ¿TIP NOT FULLY CONNECTED¿ ERROR DISPLAYED AFTER 409 REPS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744388 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL INC. TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1