BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON JET PLUS W/TAPON-115V G137(DNA)

    MDR report key: 19195930 · Received April 26, 2024

    Report

    Report Number
    2424472-2024-00033
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Report Date
    May 8, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00381875011
    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

    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

    05/07/24 CN. HPC# 12210 STERIMATE# 202112-0 A2E REG, NEEDLE VALVE, HP FLOW CONTROL CLOGGED NO POWDER FLOW DUE TO A BLOCKADE IN THE HP. DETERIORATED NOZZLE GRIP. DEBRIS BUILD UP IN THE WATER FILTER. DEAD/LOW BATTERIES IN WIRELESS FOOT PEDAL. CLEANED UP THE BLOCKADE, TESTED AND RECALIBRATED TO MANUFACTURING SPECIFICATIONS. QA BY JB.

    Description of Event or Problem · 0

    WHILE THE CUSTOMER WAS USING A CAVITRON JET PLUS G137 THEY ALLEGE THAT THE WATER, HANDPIECE AND INSERT TIP GETS HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123606 CAVITRON JET PLUS W/TAPON-115V G137(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00381875011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown