BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPTICO ENDO DTC

    MDR report key: 4212509 · Received October 27, 2014

    Report

    Report Number
    2320721-2014-00015
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    GEY
    PMA / PMN Number
    K882526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE A SUDDEN INCREASE IN SPEED COULD POSSIBLY LEAD TO FILE SEPARATION, WHICH COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE ISSUE WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR . AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE FILE SEPARATIONS WILL BE REPORTED, AS APPROPRIATE, VIA ASR. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE 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 AN ASEPTICO ENDO DTC MOTOR WAS INCREASING IN SPEED AND OVERHEATING. THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684452 ASEPTICO ENDO DTC MOTOR, SURGICAL INSTRUMENT, AC-POWER GEY DENTSPLY TULSA DENTAL SPECIALTIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1