BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM TIP

    MDR report key: 11738049 · Received April 28, 2021

    Report

    Report Number
    3011423170-2021-00045
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Report Date
    April 4, 2021
    Manufacturer
    SOLTA MEDICAL, INC
    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

    PRODUCT EVALUATION CONFIRMED THE FAILURE MODE. SERVICE CONFIRMED THE DAMAGE ON THE TIP MEMBRANE ALONG THE RF TRACE. INVESTIGATION FOUND GLOWING OR 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. THIS EVALUATION CONFIRMS CUSTOMER¿S ACCOUNT OF POSSIBLE GLOWING FROM THE TIP MEMBRANE DURING TREATMENT. DEFECTS ON THE TIP MEMBRANE CAN LEAD TO A RAISE IN TEMPERATURE OF THE TIP DURING TREATMENT AND CAN POTENTIALLY CAUSE PATIENT BURNS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. THE 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)(6).

    Additional Manufacturer Narrative · 1

    THE TIP WAS RETURNED AND EVALUATED. THE EVALUATION REVEALED THAT THE TIP PASSED FLOW, LEAK AND THERMISTOR TESTING. IT FAILED VISUAL TESTING DUE TO THE OBSERVATION OF DIELECTRIC BREAKDOWN ON THE TIP. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE EXISTENCE OF DIELECTRIC BREAKDOWN. A REVIEW OF THE DEVICE HISTORY RECORDS IS IN PROGRESS. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN. THIS INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THREE SPARKLES CAME OUT OF THE TIP EDGE AT ONCE, ALONG THE SENSORS. THE SETTING WAS AT 3.5. THE USER CLEANED THE TIP WITH ALCOHOL, THEN KEPT GOING WITH PROCEDURE ON A LOWER SETTING. NEAR THE END OF THE PROCEDURE, THE CUSTOMER HAD A BIG CRY (SETTING WAS 2.5 , OVER NECK). AN ERYTHEMATIC LINE, SAME LENGTH AS THE EDGE OF THE TOTAL TIP, WAS IMMEDIATELY OBSERVED. THE USER THAN REALIZED SOMETHING WAS WRONG WITH TIP. AT THAT TIME, THERE WERE ONLY 17 PULSES LEFT. THE SETTING WAS DOWN TO MINIMUM AND THE PROCEDURE WAS COMPLETED. MOISTURE AND RECOVERY CREAM WAS APPLIED. THE PATIENT MADE NO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633660 THERMAGE CPT SYSTEM TIP ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1