BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON BOBCAT PRO 115V-G130(DNA)

    MDR report key: 16872611 · Received May 4, 2023

    Report

    Report Number
    2424472-2023-00021
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Report Date
    June 22, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K033705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    EMN HP;CABLE,CONN/GUN CABLE KINK/PINCH/TWIST WATER LINE INSIDE THE HP CABLE TWISTED CAUSING RESTRICTING WATER FLOW TO THE HP. LEAKING WATER SOLENOID CAUSING CORROSION ON THE SCREWS OF THE HOUSING. HOUSING NEEDS TO BE BROKEN OPEN TO ACCESS INSIDE FOR EVALUATION. WILL REPLACE DAMAGED/WORN COMPONENTS AND RECALIBRATE UNIT TO FACTORY SPECS UPON ESTIMATE APPROVAL.

    Description of Event or Problem · 0

    WHILE USING A G130 CAVITRON BOBCAT PRO, THEY ALLEGE THAT THE HANDPIECE GETS HOT WHEN USING AND UNSURE IF WATER IS GETTING TO THE HANDPIECE. NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432832 CAVITRON BOBCAT PRO 115V-G130(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown