BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON JET PLUS G137

    MDR report key: 16677109 · Received April 4, 2023

    Report

    Report Number
    2424472-2023-00016
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Report Date
    May 18, 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

    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 AUY FOUND NO ISSUES WITH TIPS HEATING AS ALLEGED, CUSTOMER MAY HAVE BAD INSERT/S OR INADEQUATE WATER FLOW, DID FIND PNEUMATICS SYSTEM HAS BEEN SUBJECTED TO SOME SORT OF CONTAMINANT, POWER BOWL CORRODED, DUCK BILLS DETERIORATED, ETC, ALSO FOUND COVER CHIPPED, ESTIMATED UNIT ACCORDINGLY CUSTOMER COMPLAINT IS A KNOWN HAZARD AND IS TRACKED AS PART OF MONTHLY PSC MEETINGS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382907 CAVITRON JET PLUS G137 SCALER, ULTRASONIC ELC DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown