BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON PLUS TAP-ON (DNA) G136

    MDR report key: 17929646 · Received October 13, 2023

    Report

    Report Number
    2424472-2023-00050
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Report Date
    November 21, 2023
    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

    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.

    Additional Manufacturer Narrative · 0

    SAK EMO FOUND NO ISSUES WITH UNIT DELIVERING WATER FLOW. MAYBE CLOGGED INSERTS AT OFFICE? DID FIND OTHER ISSUES: SOLENOID/REGULATOR WONT HOLD SET PRESSURE "CREEPS" HPC AND STERI-MATE CONNECTION LEAKS WATER DRIPS, DURING OPERATION. ALSO RECOMMEND NEW WATER FILTER. ESTIMATED UNIT ACCORDINGLY. NO AUX CABLE WITH UNIT.

    Description of Event or Problem · 0

    WHILE USING A CAVIATRON PLUS G136 THEY ALLEGE THAT NO WATER WAS GETTING TO THE HANDPIECE AND THE HANDPIECE WAS GETTING HOT, NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969329 CAVITRON PLUS TAP-ON (DNA) G136 SCALER, ULTRASONIC ELC DENTSPLY LLC D00381614251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown