BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON PLUS TAP-ON(DNA) G136

    MDR report key: 18826467 · Received March 4, 2024

    Report

    Report Number
    2424472-2024-00016
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Report Date
    March 28, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00381614251
    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

    NOTES: SLG, WARRANTY, UNIT IS OVERHEATING WITH ALL INSERTS AND ALL STERIMATES. (B)(6). EMAILED BY (B)(6). LOANER. SAK W4H CUSTOMER STATES HP IS HEATING UP, FOUND NO SUCH ISSUE, RAN UNIT WITH WATER FLOW SET AT 35 CC/MIN USING FSI-10 INSERT ON MAXIMUM POWER FOR EXTENDED PERIOD WITH NO HEATING AS ALLEGED JUST NORMAL WARMTH, PROBLEM IS MOST LIKELY WITH CUSTOMERS INSERTS WHICH WERE NOT SENT WITH UNIT OR NOT SUFFICIENT WATER FLOW. DID FIND WATER SOLENOID/REGULATOR DID NOT MAINTAIN SET PRESSURE AND WOULD INCREASE IN PRESSURE, THIS HOWEVER DID NOT EFFECT FLOW. REPLACED SOLENOID WITH NEW LONG WITH INSTALLATION OF WATER FILTER. UNITS TUNING/CALIBRATION WAS VERIFIED AND ALL FUNCTIONS TESTED WITHOUT ISSUE QA-MO. NO AUX CABLE WITH UNIT. HPC 04230, STERIMATE 202301.

    Additional Manufacturer Narrative · 0

    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 THE CUSTOMER WAS USING A CAVITRON PLUS G136 THEY ALLEGE THAT THE UNIT IS OVERHEATING WITH ALL INSERTS AND STERIMATES. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943972 CAVITRON PLUS TAP-ON(DNA) G136 SCALER, ULTRASONIC ELC DENTSPLY LLC D00381614251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown