BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 11773963 · Received May 4, 2021

    Report

    Report Number
    3011423170-2021-00047
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Report Date
    April 5, 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 THAT ALL REQUIREMENTS WERE MET. NO PATIENT INJURY WAS NOTICED DURING TREATMENT. INVESTIGATION FOUND GLOWING OR SPARKING FROM TIP MEMBRANE IS 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.

    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 A BROKEN MEMBRANE AND 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 DISTRIBUTOR REPORTED THAT A SPARK OCCURRED AT REP 371 DURING A THERMAGE TREATMENT. IT WAS REPORTED THERE WAS A BURNING SMELL AND A FLASH WAS SEEN. A BURN MARK WAS SEEN ON THE RADIO FREQUENCY TRACE OF THE TIP. THERE WAS ONLY ONE ERROR DISPLAYED DURING THE TREATMENT. THE PRACTITIONER CHANGED THE TIP AND PROCEEDED WITH THE TREATMENT, THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668777 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL INC. TTNS3.00E4-900 222

    Patients

    Seq Age Sex Outcome Treatment
    1