BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM TIP

    MDR report key: 14255511 · Received April 29, 2022

    Report

    Report Number
    3011423170-2022-00048
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 2, 2022
    Manufacturer
    SOLTA MEDICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATA LOG FROM THE EVENT WAS REVIEWED AND IT WAS CONFIRMED THE HANDPIECE AND SYSTEM WERE OPERATING AS EXPECTED. THE TREATMENT TIP HAS BEEN RETURNED TO THE MANUFACTURER, HOWEVER NOT YET EVALUATED. A PLANT EVALUATION IS UNDERWAY.

    Additional Manufacturer Narrative · 0

    THE TREATMENT TIP WAS EVALUATED AND IT HAD PASSED THE FLOW AND LEAK TEST BUT FAILED VISUAL INSPECTION DUE TO DIELECTRIC BREAKDOWN ALONG THE RADIO FREQUENCY (RF) TRACE ON THE TIP MEMBRANE. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED IN THIS CONDITION. BREAKDOWN OF THE DIELECTRIC MATERIAL CAN CAUSE THE RF ENERGY, DELIVERED BY THE SYSTEM, TO FOCUS IN A SMALL AREA OF THE MEMBRANE, RATHER THAN TO BE UNIFORMLY DISTRIBUTED OVER THE ENTIRE MEMBRANE AREA. DEFECTS ON THE TIP MEMBRANE CAN LEAD TO A RAISE IN TEMPERATURE OF THE TIP DURING TREATMENT AND CAN POTENTIALLY CAUSE PATIENT BURNS. DAMAGE TO THE RF TRACE CAN ALSO CAUSE THE REPORTED SPARKING NOTICED DURING TREATMENT. THERMAGE CPT SYSTEM TECHNICAL USER¿S MANUAL INSTRUCTS THE OPERATOR TO INSPECT THE TREATMENT TIPS FOR ANY SIGNS OF PHYSICAL DAMAGE PRIOR, DURING, AND AFTER TREATMENT. WITH RESPECT TO ALL THERMAGE SYSTEMS CLINICIANS SHOULD FREQUENTLY INSPECT THE TIP MEMBRANE DURING TREATMENT FOR SIGNS OF BREAKDOWN AND BUILD-UP OF FOREIGN SUBSTANCES. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. INVESTIGATION FOUND STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE THAT DAMAGED THE RF TRACE, CAUSES ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE. BASED ON THE AVAILABLE INFORMATION, THIS EVENT WAS MOST LIKELY CAUSED BY DAMAGE ON THE TIP MEMBRANE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT DURING A THERMAGE TREATMENT THEY OBSERVED SPARKS COMING FROM THE TIP AND A BURNING SMELL. SOLTA MEDICAL BRANDED CRYOGEN AND ONE AND A HALF BOTTLE OF COUPLING FLUID WAS USED ON THE PATIENT WITH THE HIGHEST LEVEL OF TREATMENT AT 4.0. AFTER DELIVERING APPROXIMATELY 1000 PULSES, THE TIP HAD BEGUN TO SPARK, AND THE USER FACILITY HAD SMELLED A BURNING ODOR. THEY HAD INSPECTED THE TREATMENT TIP PRIOR TO USE AND THROUGHOUT THE PROCEDURE EVERY 500 PULSES WITH NO DISCREPANCIES FOUND. THE PATIENT NOTED THEY HAD A MINOR BURN ON THEIR LOWER CHEEK AND SOME TINY SCABS ON ONE SIDE OF THEIR FACE THREE HOURS AFTER THE PROCEDURE. THE PHOTOS OF THE PATIENT WERE REVIEWED AND THERE WAS NO SERIOUS INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079002 THERMAGE CPT SYSTEM TIP ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL INC TTNS3.00E4-1200 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown