BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON JET PLUS W/TAPON -115V G137

    MDR report key: 17198066 · Received June 26, 2023

    Report

    Report Number
    2424472-2023-00033
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Report Date
    July 31, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    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 EMH FOUND HPC WATER FLOW NON FUNCTIONAL, NO WATER FLOW. REPLACED HPC WITH NEW, ALSO INSTALLED NEW WATER FILTER AND PINCH TUBE, UNIT THEN TUNED/CALIBRATED AND ALL FUNCTIONS TESTED QA-RB. NO JET-MATE WITH UNIT.

    Description of Event or Problem · 0

    WHILE USING A CAVITRON JET PLUS G137, THEY ALLEGE THAT THEY HAD LOW WATER PRESSURE AND THE HANDPIECE WAS GETTING HOT. NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841818 CAVITRON JET PLUS W/TAPON -115V G137 SCALER, ULTRASONIC ELC DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown