BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE TIP

    MDR report key: 8080213 · Received November 16, 2018

    Report

    Report Number
    3011423170-2018-00114
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Report Date
    October 19, 2018
    Manufacturer
    SOLTA MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION CONFIRMED THE FAILURE MODE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. NO PATIENT INJURY WAS NOTICED DURING TREATMENT. SERVICE CONFIRMED DAMAGE ON THE TIP MEMBRANE ALONG THE RF TRACE. INVESTIGATION FOUND FLAME/SPARK 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. NO CORRECTIVE ACTION IS NECESSARY. COMPLAINT TYPE IDENTIFIED WITHIN RISK ANALYSIS AND PERFORMING WITHIN ANTICIPATED RATE. 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 090518-001. THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE TIP WAS RECEIVED FOR EVALUATION. THE TIP WAS USED AT 12:10:20 PM ON 10/18/2018 TIP WAS USED FOR 106 TREATMENTS. TIP PASSED FLOW TEST, FAILED VISUAL FOR DIELECTRIC BREAKDOWN, LEAK AND FUNCTIONAL TEST WERE NOT PERFORMED. THERMISTER TEST PASSED (T0:23.38 ,T1:23.11 ,T2:22.92 ,T3:23.57 ). DIELECTRIC BREAKDOWN WAS SEEN. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THERE WAS A SPARK FROM ONE OF THEIR TIPS. THEY CHANGED THE TIP IMMEDIATELY AND THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920826 THERMAGE TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL TTNS3.00E4-900

    Patients

    Seq Age Sex Outcome Treatment
    1