BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON PLUS TAP-ON(DNA) G136

    MDR report key: 23367252 · Received October 23, 2025

    Report

    Report Number
    2424472-2025-00146
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Report Date
    December 8, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00381840011
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 11/10/2025. HPC # - 09230. ST/HP # - 201505. EAH BAT ,CHGR, CONTACT DAMAGED. THE FC IS DAMAGED, NO OPERATIONS WHEN FC IS PRESSED, RESTRICTING WATER FLOW AND VIBRATION, FC BASE PAD IS PEELING OFF, DAMAGED FC BATTERY DOOR, OPEN WATER SOLENOID, CANNOT HOLD PRESSURE, DEBRIS IN WATER HOSE, RUSTED QD, CRACKED HOUSING BASE, CRACKED OVERLAY BOARD. CHECK CALIBRATION. THE UNIT WILL BE REPAIRED UPON ESTIMATES APPROVAL.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE LACK OF WATER FLOW HAS CAUSED AN OVERHEATING INSERT. SINCE AN OVERHEATING INSERT 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.

    Description of Event or Problem · 0

    WHILE USING A CAVITON PLUS G136 THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730643 CAVITRON PLUS TAP-ON(DNA) G136 SCALER, ULTRASONIC ELC DENTSPLY LLC D00381840011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown