BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K THINSERT FITGRIP ULTRASONIC INSERT

    MDR report key: 4602796 · Received March 11, 2015

    Report

    Report Number
    2424472-2015-00009
    Event Type
    Malfunction
    Date Received
    March 11, 2015
    Report Date
    February 11, 2015
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INSERT WAS EVALUATED AND OPERATED FOR AN EXTENDED DURATION. THE HOTTEST OBSERVED TEMPERATURE WAS 88.6 F. THIS IS WITHIN THE LIMITS FOR SAFE OPERATION. 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 THINSERT-FG INSERT TIP OVERHEATED; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169592 30K THINSERT FITGRIP ULTRASONIC INSERT ULTRASONIC SCALER ELC DENTSPLY PROFESSIONAL 4314

    Patients

    Seq Age Sex Outcome Treatment
    1