BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 13017791 · Received December 16, 2021

    Report

    Report Number
    3011423170-2021-00139
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 9, 2021
    Report Date
    November 16, 2021
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREATMENT TIP WAS RETURNED FOR EVALUATION. SERVICE CONFIRMED BURNT RADIO FREQUENCY TRACE ON THE TIP MEMBRANE WHICH MOST LIKELY CAUSED THE REPORTED SPARKING DURING TREATMENT. THIS EVALUATION CONFIRMS CUSTOMER¿S ACCOUNT OF POSSIBLE SPARKING FROM THE TIP MEMBRANE DURING TREATMENT. DEFECTS ON THE TIP MEMBRANE CAN LEAD TO A RISE IN TEMPERATURE OF THE TIP DURING TREATMENT AND CAN POTENTIALLY CAUSE PATIENT BURNS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. NO PATIENT INJURY WAS REPORTED DURING TREATMENT. PRIOR INVESTIGATION HAS FOUND GLOWING OR SPARKING FROM THE TIP MEMBRANE IS CAUSED BY STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE WHICH DAMAGES THE RADIO FREQUENCY TRACE, CAUSING ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE. ALL TREATMENT TIPS ARE VISUALLY INSPECTED FOR DEFECTS DURING MANUFACTURING AND PACKAGING.

    Additional Manufacturer Narrative · 0

    TREATMENT TIP WAS RETURNED AND EVALUATED. EVALUATION WAS UNABLE TO CONFIRM ANY FUNCTIONAL PROBLEM WITH THE TIP. THE TIP HAS A BURNT TRACE ON THE TIP SURFACE. THE TIP PASSED FLOW AND THERMISTOR TESTS. THE TIP FAILED LEAK TESTING AND VISUAL INSPECTION. DIELECTRIC MEMBRANE BREAKDOWN WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD IS UNDERWAY. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 0

    TREATMENT TIP HAS BEEN REQUESTED BUT NOT YET RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS UNDERWAY. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED TO THEIR SALES REPRESENTATIVE THAT THEY HAD A THERMAGE TREATMENT TIP WHICH SPARKED DURING A TREATMENT THE PREVIOUS WEEK. THE CLINIC CONFIRMED THERE WAS NO PATIENT INJURY FROM THE SPARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918594 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL INC. TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown