BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON SELECT SPS G124 GENERATOR(DNA)

    MDR report key: 19324067 · Received May 15, 2024

    Report

    Report Number
    2424472-2024-00042
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Report Date
    June 17, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003813021
    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

    (B)(4). 06/12/24 EVALUATION TECH: JCB. EMH HP; CABLE, CONN/GUN CABLE DAMAGED. INTERMITTENT OR NO OPERATION DUE TO AN OPEN CONDITION IN THE HANDPIECE CABLE. NO WATER FLOW DUE TO A CLOGGED WATER SOLENOID, CLOGGED WATER FILTER RESTRICTING WATER FLOW. WILL REPLACE DAMAGED/WORN COMPONENTS AND RECALIBRATE UNIT TO FACTORY SPECS UPON ESTIMATE APPROVAL: *LOANER FEE HAS BEEN INCLUDED IN THE ESTIMATE.

    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.

    Description of Event or Problem · 0

    WHILE USING A CAVITRON SELECT SPS G124 THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS HEATING UP; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671008 CAVITRON SELECT SPS G124 GENERATOR(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D003813021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown