BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 10S STRAIGHT

    MDR report key: 8621680 · Received May 17, 2019

    Report

    Report Number
    2424472-2019-00082
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    May 17, 2019
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 21 CFR PART 803. VISUALLY INSPECTED AND VERIFIED THE INSERT HAS A BEND IN THE LAMINATION STACK DOES NOT MEET SPEC COULD NOT BE TESTED.

    Description of Event or Problem · 1

    WHILE USING A 30K FSI-SLI-FG-10S INSERT, THERE WAS BAD WATER FLOW AND THE INSERT WAS GETTING HOT; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414752 30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 10S STRAIGHT SCALER, ULTRASONIC ELC DENTSPLY LLC NA 18331,00018863

    Patients

    Seq Age Sex Outcome Treatment
    1