BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM TIP

    MDR report key: 12050451 · Received June 23, 2021

    Report

    Report Number
    3011423170-2021-00065
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 24, 2021
    Report Date
    May 25, 2021
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SERVICE CONFIRMED BURNT TRACE ON THE TIP SURFACE MEMBRANE ALONG THE RADIOFREQUENCY TRACE, WHICH CAUSES THE REPORTED ISSUE DURING TREATMENT. THE INVESTIGATION FOUND SPARKING FROM THE TIP MEMBRANE ARE CAUSED BY STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE THAT DAMAGED THE RF TRACE, CAUSING ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR SERIAL/LOT NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND EVALUATED. DIELECTRIC BREAKDOWN WAS SEEN SO THE TIP WAS NOT USED IN A FUNCTIONAL TEST. THE TIP WAS USED FOR (525) TREATMENTS. THE TIP PASSED THE FLOW TEST AND FAILED THE LEAK TEST. THE VISUAL INSPECTION FAILED AS DIELECTRIC BREAKDOWN WAS OBSERVED. THE TIP ALSO FAILED THE THERMISTOR TEST. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AFTER AROUND 300-400 REPS THEY SAW A SPARK FROM THE TIP. THEY CHANGED TIPS AND HAD NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947336 THERMAGE CPT SYSTEM TIP ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1