BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STYLUS STANDARD HANDPIECE

    MDR report key: 4212505 · Received October 27, 2014

    Report

    Report Number
    1419322-2014-00069
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K003518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. DENTSPLY WAS ABLE TO VERIFY THE COMPLAINT. MICROSCOPIC EVALUATION REVEALED SIGNIFICANT DEBRIS BUILDUP INSIDE THE CAP AND HEAD CAVITIES AND SIGNIFICANT WEAR WAS ALSO SEEN ON THE INSIDE SURFACE OF THE BUTTON THAT FACES THE PUSHER AND THE PUSHER ITSELF. THIS INDICATES SEVERE INTERACTION BETWEEN THESE TWO MECHANISMS AT HIGH ROTATIONAL SPEEDS WHICH CREATED HEAT. ALL COMPONENTS LOOKED DRY WITH NO PRESENCE OF LUBRICATION. ROOT CAUSE: CAP, MAINTENANCE/DEBRIS.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT A STYLUS HANDPIECE OVERHEATED. THERE WAS NO INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684270 STYLUS STANDARD HANDPIECE AIR-POWERED DENTAL HANDPIECE EFB DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1