BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM TIP

    MDR report key: 14521924 · Received May 27, 2022

    Report

    Report Number
    3011423170-2022-00066
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    February 4, 2022
    Report Date
    February 4, 2022
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE CAME IN AS AN EVENT CODE OF HIGH IMPEDANCE. THE PRODUCT WAS RETURNED AND EVALUATED AND SERVICE WAS UNABLE TO CONFIRM THE CUSTOMER COMPLAINT BUT RECEIVED AN EVENT CODE THAT THE TIP WAS NOT FULLY CONNECTED. THE TIP WAS USED FOR 240 TREATMENTS AND PASSED THE FLOW TEST. THE TIP FAILED THE LEAK TEST. THE TIP ALSO FAILED THE THERMISTOR TEST AND VISUAL INSPECTION AS DIELECTRIC BREAKDOWN WAS OBSERVED. THE PLANT INVESTIGATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    SERVICE WAS UNABLE TO CONFIRM THE CUSTOMER COMPLAINT. HOWEVER, DIELECTRIC BREAKDOWN WAS OBSERVED RESULTING IN A MALFUNCTION. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENT WERE MET. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSIONS CAN BE DRAWN. NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED AN ERROR MESSAGE OF HIGH IMPEDANCE WITH A THERMAGE CPT TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2639377 THERMAGE CPT SYSTEM TIP ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS0.25NB1-450 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown