BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON JET PLUS TAP-ON(DNA) G137

    MDR report key: 19381182 · Received May 23, 2024

    Report

    Report Number
    2424472-2024-00048
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Report Date
    June 20, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00381614281
    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

    HPC-10120. JETMATE-05120. 06/17/24 EVALUATION TECH: JCB. AUY PLUMBING/MANIFOLD OIL/MOISTURE. UNIT HAS BEEN CROSSLINED, WATER IN THE AIR SYSTEM, CAUSING POWDER TO STICK TOGETHER AND HARDEN IN THE MANIFOLD AND BOWL ASSEMBLY, OIL/WATER CONTAMINATION IN THE AIR SUPPLY HOSE, CLOGGED DUCKBILL FILTER CAUSING POOR AIR/POWDER FLOW, FLATTENED PINCH TUBE RESTRICTING AIR/POWDER FLOW, NO POWDER FLOW DUE TO A CLOGGED POWDER BOWL, NO POWDER FLOW DUE TO A CLOGGED L/J-NOZZLE. NO WATER FLOW DUE TO RUST BUILDUP IN THE SOLENOID PREVENTING PROPER OPERATION, DEBRIS BUILDUP IN THE WATER SUPPLY HOSE, DEBRIS BUILDUP IN THE WATER FILTER. LOW VIBRATION DUE TO MALFUNCTION WITH THE MAIN OSCILLATOR BOARD, CRACKED AUXILIARY FOOT PEDAL CONNECTOR ON THE POWER DRIVE BOARD. POOR COMMUNICATION WITH THE WIRELESS FOOT PEDAL, INTERMITTENT OR NO OPERATION DUE TO AN OPEN CONDITION IN THE HANDPIECE CABLE, CORRODED CONTACT PINS ON THE JET-MATE HANDPIECE. CABINET IS CRACKED. WILL REPLACE DAMAGED/WORN COMPONENTS AND RECALIBRATE UNIT TO FACTORY SPECS UPON ESTIMATE 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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    WHILE USING A CAVITRON JET PLUS G137 THEY ALLEGE THAT THEY ARE NOT GETTING ENOUGH WATER TO THE HANDPIECE AND THE HANDPIECE AND INSERTS ARE GETTING WARM, NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500976 CAVITRON JET PLUS TAP-ON(DNA) G137 SCALER, ULTRASONIC ELC DENTSPLY LLC D00381614281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown