BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE TIP

    MDR report key: 7861959 · Received September 10, 2018

    Report

    Report Number
    3011423170-2018-00091
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Report Date
    August 21, 2018
    Manufacturer
    SOLTA MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED. THE FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR SERIAL/LOT NUMBER (B)(4) , MANUFACTURING DATE 05/30/2018. PRODUCT EVALUATION WAS PERFORMED FOR P/N#TTNS3.00E4-1200 LOT#053018 S/N#23B421 ON (B)(6)2018. THE TIP PASSED FLOW AND THERMISTOR TESTING. THE TIP FAILED LEAK TESTING AND VISUAL TESTING DUE TO THE OBSERVATION OF DIELECTRIC BREAKDOWN. NO FUNCTIONAL TEST WAS PERFORMED DUE THE PRESENCE OF DIELECTRIC BREAKDOWN/DAMAGE ALONG THE RF TRACE OF THE TIP. DEFECTS ON THE TIP MEMBRANE CAN LEAD TO A RISE IN TEMPERATURE OF THE TIP AND CAN POTENTIALLY CAUSE PATIENT BURNS DURING TREATMENT. THE INVESTIGATION FOUND THAT FLAMES/SPARKS FROM 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. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT YET BEEN EVALUATED. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    PRACTITIONER REPORTED OBSERVING A SPARK/ARC FROM THE END OF THE THERMAGE TIP DURING A TREATMENT AT 130 PULSES. THE PRACTITIONER ACTIVATED THE TIP AGAIN AND OBSERVED THE SAME EFFECT. PRACTITIONER REPLACED THE TIP AND CONTINUED WITH THE TREATMENT. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702785 THERMAGE TIP ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL TTNS3.00E4-1200

    Patients

    Seq Age Sex Outcome Treatment
    1