BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K THINSERT FITGRIP ULTRASONIC INSERT

    MDR report key: 5200507 · Received November 4, 2015

    Report

    Report Number
    2424472-2015-00094
    Event Type
    Malfunction
    Date Received
    November 4, 2015
    Report Date
    October 6, 2015
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO MANUFACTURING ISSUES IDENTIFIED. INSERT WAS TESTED AND THE ISSUE COULD NOT BE REPLICATED. TEMPERATURE OF INSERT WAS WITHIN LIMITS FOR SAFE USE.

    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.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A CAVITRON 30K CAV.THINSERT-FG INSERT TIP OVERHEATED; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733075 30K THINSERT FITGRIP ULTRASONIC INSERT SCALER, ULTRASONIC ELC DENTSPLY PROFESSIONAL NA 5175

    Patients

    Seq Age Sex Outcome Treatment
    1