BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 14749633 · Received June 20, 2022

    Report

    Report Number
    3011423170-2022-00079
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 20, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATACARD LOGS AND TREATMENT TIP WERE EVALUATED. BASED ON THE EVALUATION OF THE DATA, THE HANDPIECE AND SYSTEM PERFORMED AS EXPECTED. THE TIP PASSED THE FLOW TEST, LEAK TEST AND THERMISTOR TEST. THE TIP FAILED VISUAL INSPECTION AS DIELECTRIC BREAKDOWN WAS OBSERVED. NO FUNCTIONAL TESTING WAS PERFORMED AS THE TIP WAS FULLY USED. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW, WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. DATACARD LOGS SHOWED THE HANDPIECE AND SYSTEM PERFORMED AS EXPECTED. DURING EVALUATION OF THE TREATMENT TIP, SERVICE FOUND DAMAGE TO THE TIP MEMBRANE. DIELECTRIC MEMBRANE DAMAGE TO TIP MEMBRANE CAN CAUSE RISK TO PATIENT. BASED ON THE AVAILABLE INFORMATION, THE PAIN REPORTED DURING TREATMENT WAS CAUSED BY DAMAGE TO THE TIP MEMBRANE. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE DEVICE COULDN'T GO HIGHER THAN ONE ON VIBRATION AND THEN ERROR CODES PREVENTED USE OTHER THAN WITH VIBRATION OFF. THE TREATMENT WAS UNABLE TO BE COMPLETED. IT WAS ALSO REPORTED THAT A PATIENT EXPERIENCED EXCESSIVE PAIN DURING A PROCEDURE THAT RESULTED IN INCOMPLETE PROCEDURE WITH SUBOPTIMAL RESPONSE. THE MEDICAL REVIEWER HAS DEEMED THIS AS NOT SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189394 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown