BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR:ASEPTICO DTC

    MDR report key: 22703819 · Received August 4, 2025

    Report

    Report Number
    2320721-2025-00076
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Report Date
    August 22, 2025
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    EKX
    UDI-DI
    10817417020821
    PMA / PMN Number
    K030163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED. MODEL: AEU-25T; AE-4B-30; AE-7P; 840001. SERIAL #: (B)(6). OPENING COMMENTS BY JAMIE: LOSES SPEED WHEN APPLYING PRESSURE. CLOSING COMMENTS: CONSOLE REPLACED OVERLAY, UPDATED SOFTWARE TO TUL06, TESTED OKAY. MOTOR (B)(4) REPAIRED THE CABLE, REPLACED BOTH BEARINGS AND O-RINGS, TESTED OKAY. FOOT PEDAL AND THE PWR CORD TESTED OKAY.

    Description of Event or Problem · 0

    IN THIS EVENT IT WAS REPORTED AN MOTOR: ASEPTICO DTC WAS RUNNING TO SLOW. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833733 MOTOR:ASEPTICO DTC HANDPIECE, DIRECT DRIVE, AC-POWERED EKX TULSA DENTAL PRODUCTS LLC 10817417020821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown