BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON PLUS PACKAGE-2015

    MDR report key: 21801434 · Received April 8, 2025

    Report

    Report Number
    2424472-2025-00211
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Report Date
    July 11, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    DHR REVIEW IS NOT REQUIRED BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION AND THE CUSTOMER COMPLAINT IS A KNOWN HAZARD. BASED ON THE REPAIR NOTES, THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE FAILURE AS STATED IN THE COMPLAINT. RECOMMENDED REPAIRS WERE MADE AS PART OF PREVENTIVE MAINTENANCE. REPAIR NOTES: HPC LOT # - 05240. ST/HP LOT # - 202312. EAH: THE FC BATTERIES ARE DEAD, RESTRICTING OPERATIONS. CUSTOMERS COMPLAINT WAS NOT REPLICATED, CUSTOMERS INSERT MAY BE CLOGGED, RESTRICTING WATER FLOW, CAUSING THE HP TO HEAT UP. UNIT HAVE BEEN CALIBRATED AND TESTED TO FACTORY'S SPECS. NO OTHER FAULTS WERE FOUND. PC AND AUX CABLE WERE NOT SENT IN FOR EVALUATIONS.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A CAVITRON PLUS PACKAGE-2015 HP GETS HOT AND THE WATER FLOW NEEDS TO BE CALIBRATED AS THERE IS NOT ENOUGH AND AT TIMES TOO MUCH WATER FLOW. NO INJURY. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223946 CAVITRON PLUS PACKAGE-2015 SCALER, ULTRASONIC ELC DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown