BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 14397954 · Received May 13, 2022

    Report

    Report Number
    3011423170-2022-00053
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    January 22, 2022
    Report Date
    April 14, 2022
    Manufacturer
    SOLTA MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREATMENT TIP AND SYSTEM DATA WERE RETURNED AND EVALUATED. SYSTEM LOG EVALUATION SHOWED THAT THE SYSTEM AND HAND PIECE PERFORMED AS EXPECTED. TREATMENT TIP PASSED FLOW AND THERMISTOR TESTING. TREATMENT TIP FAILED THE LEAK TEST. VISUAL INSPECTION FAILED DUE TO THE OBSERVATION OF DIELECTRIC BREAKDOWN ON THE RADIO FREQUENCY TRACE. NO DENTS OR SCRATCHES WERE OBSERVED. NO FUNCTIONAL TESTING WAS POSSIBLE DUE TO THE CONDITION OF THE RETURNED PRODUCT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. A MEDICAL REVIEW OF THE CASE DETERMINED THAT THIS EVENT WAS NOT A SERIOUS INJURY. SERVICE CONFIRMED DAMAGE TO THE TIP MEMBRANE ALONG THE RADIO FREQUENCY TRACE. INVESTIGATION FOUND STRESS CONCENTRATIONS ON THE FLEX ASSEMBLY AT THE ADHESIVE EDGE DAMAGE THE RADIO FREQUENCY TRACE, CAUSING ARCING AND SUBSEQUENT BURN-THROUGH OF THE FLEX CIRCUIT MEMBRANE. BASED ON THE AVAILABLE INFORMATION, BURNS THAT OCCUR DURING TREATMENT WERE MOST LIKELY CAUSED BY DAMAGE ON THE TIP MEMBRANE.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED THAT A PATIENT HAD EXPERIENCED A BURN ON THEIR FOREHEAD FOLLOWING A THERMAGE CPT FACE PROCEDURE. THE CLINIC REPORTED THAT THE PATIENT WAS TREATED AT A MAXIMUM POWER LEVEL OF 5.5 AND THE CORRECT AMOUNT OF COUPLING FLUID WAS USE. THE TREATMENT TIP WAS INSPECTED PRIOR TO USE. TIP INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES. THE CLINIC REPORTED THAT AT AROUND 650 REPS THE PATIENT COMPLAINED OF A BURNING SMELL WHILE THE DOCTOR WAS TREATING THEIR FOREHEAD. THE DOCTOR RE-INSPECTED THE TIP AT THIS POINT AND FOUND NO ABNORMALITIES. THE TREATMENT WAS COMPLETED WITH A SECOND TIP WITHOUT ISSUE. FOLLOWING TREATMENT THE PATIENT COMPLAINED OF PAIN ON THE FOREHEAD. IT WAS NOTED AT THIS POINT THAT ERYTHEMA WAS VISIBLE ON THE FOREHEAD. PHOTOS OF THE PATIENT WERE REVIEWED AND IT WAS DETERMINED BY THE MEDICAL EVALUATOR THAT THIS DOES NOT CONSTITUTE A SERIOUS INJURY REPORTABLE EVENT. UPON DEVICE RETURN AND EVALUATION A REPORTABLE MALFUNCTION WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025085 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL INC. TTNS3.00E4-900 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown