BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPTICO ENDO ITR MOTOR

    MDR report key: 3916403 · Received May 22, 2014

    Report

    Report Number
    2320721-2014-00005
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    EKX
    PMA / PMN Number
    K030163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVALUATION ON THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE SEPARATION OF A FILE 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 DEVICE MALFUNCTIONED AND THAT THE MALFUNCTION 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 SEPARATION WILL BE REPORTED VIA ASR, AS APPROPRIATE. 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 A DOCTOR REPORTED THAT AN ASEPTICO TORQUE MOTOR'S TORQUE SETTING WAS STUCK ON 1, POSSIBLY CAUSING A FILE TO SEPARATE; THE SEPARATED PIECE WAS INCORPORATED INTO THE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304398 ASEPTICO ENDO ITR MOTOR DIRECT DRIVE, AC-POWERED HANDPIECE EKX DENTSPLY TULSA DENTAL SPECIALTIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1