BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON SELECT SPS G124 GENERATOR(DNA)

    MDR report key: 16868862 · Received May 4, 2023

    Report

    Report Number
    2424472-2023-00020
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Report Date
    May 18, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K970123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAK 000 FOUND NO ISSUES WITH UNIT HEATING UP AS ALLEGED, UNIT MEETS ALL SPECIFICATIONS PROBLEM IS LIKELY INSERT ISSUE (AFTERMARKET INSERTS) OR INADEQUATE WATER FLOW QA-RB DHR REVIEW IS NOT REQUIRED BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION. NO FAULT WAS FOUND WITH RETURNED UNIT. NO FURTHER ACTION REQUIRED.

    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.

    Description of Event or Problem · 0

    WHILE THE CUSTOMER WAS USING A G124 CAVITRON SELECT SPS, THEY ALLEGE THAT CONTROL PANEL GETS HOT AND THE INSERTS BECOME HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487015 CAVITRON SELECT SPS G124 GENERATOR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown