BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 2511520 · Received March 16, 2012

    Report

    Report Number
    1419322-2012-00008
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Report Date
    February 17, 2012
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS INVOLVING THIS DEVICE THAT RESULTED IN THE NEED FOR MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE RETURNED DEVICE WAS EVALUATED AND THE OVERHEATING ISSUE WAS REPRODUCED. WORN CHIP AIR AND WATER SEALING O-RINGS WERE NOTED. THIS ISSUE WAS POSSIBLY CAUSED BY INSUFFICIENT LUBRICATION WHICH RESULTED IN EXCESSIVE FRICTION.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT AN ESTYLUS 1:5 HANDPIECE REPORTEDLY OVERHEATED. NO PATIENT WAS INVOLVED AS THE ISSUE WAS NOTED BY THE DOCTOR DURING MAINTENANCE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1