BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD REVOLUTION

    MDR report key: 15665773 · Received October 25, 2022

    Report

    Report Number
    3006680097-2022-00003
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    September 29, 2022
    Report Date
    November 24, 2022
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K141657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRESENT REPORT IS AN INITIAL REPORTED SUBMITTED BY THD SPA, AS MANUFACTURER OF THD REVOLUTION DEVICE, SUSPECTED OF MALFUNCTION. SINCE THD SPA HAS NOT YET RECEIVED THE DEVICE FOR DIRECT INVESTIGATION, PRODUCTION DOCUMENTATION RELATED TO THD REVOLUTION DEVICE, SN (B)(4), WAS PERFORMED. PRODUCTION DOCUMENTATION DID NOT HIGHLIGHT ANY ANOMALY AND THD REVOLUTION DEVICE SN (B)(4), DURING INCOMING INSPECTION, WAS ALSO SUBJECTED TO SAMPLING CONTROLS INCLUDING FUNCTIONAL CONTROL AND DOPPLER SOUND RESULTED NORMALLY AUDIBLE, THEREFORE THD SPA CONSIDERS THE SUSPECTED MALFUNCTION (ABSENCE OF DOPPLER SOUND), COMPATIBLE WITH A DAMAGE OF DEVICE OR AN EVENT OCCURRED AFTER THE RELEASE OF THE DEVICE ITSELF (FOR EXAMPLE AN EVENT OCCURRED DURING TRANSPORT AND/OR IMPROPER HANDLING DURING UNBOXING). COMPLAINTS TREND ANALYSIS DID NOT HIGHLIGHT ANY SIMILAR EVENT ON THE SAME LOT OF DEVICES TO DATE. FOLLOWING THE DIRECT INSPECTION OF THD REVOLUTION, WE WILL REPORT ADDITIONAL INFORMATION ON FINAL REPORT.

    Additional Manufacturer Narrative · 0

    WE REPORT HERE ADDITIONAL INFORMATION CONCERNING THE MFR REPORT 3006680097-2022-00003. WE WOULD LIKE TO EMPHASIZE THAT IT WAS POSSIBLE TO PROVIDE THIS FOLLOW-UP REPORT AS THE DEVICE, RETURNED FROM THE UNITED STATES, SUFFERED A SIGNIFICANT DELIVERY DELAY DURING THE CUSTOMS CLEARANCE PROCEDURES, THEREFORE IT WAS POSSIBLE FOR US TO INVESTIGATE IT, TOGETHER WITH OUR DEVELOPERS, ONLY ON 11/21/2022. TECHNICAL INVESTIGATION OF THE THD DOPPLER DEVICE, THD REVOLUTION, PERFORMED ON 11/21/2022 BY THD SUPPLIER FOUND THAT IT IS A FAULTY 8MHZ QUARTZ. THIS TYPE OF DEFECT CAN OCCUR WHEN THE QUARTZ HAS CAPACITY CHARACTERISTICS THAT ARE AT THE LIMIT OF ACCEPTANCE TOLERANCES; WHEN TOLERANCES ARE EXCEEDED, THE OSCILLATOR CAN BEHAVE AS DESCRIBED. TO DATE THIS IS THE FIRST TIME THAT THD SPA EXPERIENCE THIS TYPE OF MALFUNCTION ON THD REVOLUTION DEVICE AND COMPLAINT ANALYSIS DID NOT HIGHLIGHT ANY SIMILAR REPORT ON THE SAME BATCH OF THD REVOLUTION DEVICES NOR ON OTHER BATCHES FROM WHEN THE DEVICE IS ON THE MARKET (FROM 2013), WITH AN ESTIMATED USES, THAT ON THE BASE OF PMS DATA IS OF MORE THAN 180.000 SURGICAL TREATMENTS THAT INVOLVES THD REVOLUTION IN THE WORLD. THEREFORE WE CONSIDER THE PRESENT COMPLAINT AS A QUITE INCREDIBLE (FREQUENCY OF THE EVENT BETWEEN 10-5 AND 10-6) AND RELATED TO AN ISOLATED COMPONENT FAILURE THAT, SINCE IT IS AN INTERMITTENT MALFUNCTIONING, IT WAS VERY UNLIKELY TO BE IDENTIFIABLE DURING THE IN-PROCESS CONTROLS, NOR DURING THE ACCEPTANCE CONTROLS WHICH, IN FACT, RESULTED CONFORM RESPECT TO DEVICE SPECIFICATIONS AND LED TO THE RELEASE OF THE DEVICE ITSELF. WE THEREFORE CONSIDER THE EVENT A VERY RARE AND ISOLATED PROBLEM COMPATIBLE WITH A MANUFACTURING DEFECT OF THE QUARTZ CRYSTAL COMPONENT NOT DETECTABLE AT THE TIME OF THE PRODUCTION CHECKS, BUT HIGHLIGHTED ONLY AFTER USE OF THE DEVICE. BASED ON THESE CONSIDERATIONS, THE CONTROLS IN PLACE IN THE MANUFACTURING PROCESS ARE CONSIDERED TO BE STILL VALID AND SUITABLE FOR INTERCEPTING KNOWN DEFECTS IN THE THD REVOLUTION PRODUCT, REGARDLESS OF THIS EVENT, WHICH FOR THE ABOVE IS TRULY RARE. IN ANY CASE THD WILL CONTINUE TO MONITOR FEEDBACK FROM THE MARKET TO DETECT ANY RE-OCCURRENCES FOR THIS TYPE OF MALFUNCTION, WHICH ON THE BASIS OF THE KNOWN QUANTITATIVE DATA IS CONSIDERED, TO DATE, QUITE INCREDIBLE.

    Description of Event or Problem · 0

    NO DOPPLER SOUND CAN BE HEARD FROM THD REVOLUTION DEVICE DURING A T.H.D. TREATMENT, ONLY STATIC NOISE CAN BE HEARD. THE TREATMENT WAS COMPLETED WITH A DIFFERENT TECHNIQUE WITHOUT ANY CONSEQUENCE FOR THE PATIENT.

    Description of Event or Problem · 0

    SUPPLEMENTAL SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666060 THD REVOLUTION THD REVOLUTION JAF THD SPA 700017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown