BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT

    MDR report key: 4943580 · Received July 23, 2015

    Report

    Report Number
    2424472-2015-00042
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INSERT WAS EVALUATED AND THE HOTTEST OBSERVED TEMPERATURE WAS 92.4F. THIS WAS WELL WITHIN THE LIMITS FOR SAFE USE. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A CAVITRON 30K FSI-SLI-10S INSERT TIP OVERHEATED; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481271 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT ULTRASONIC SCALER ELC DENTSPLY PROFESSIONAL 5119

    Patients

    Seq Age Sex Outcome Treatment
    1