BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART ENDO MOTOR

    MDR report key: 6182886 · Received December 16, 2016

    Report

    Report Number
    2320721-2016-00067
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 16, 2016
    Report Date
    February 24, 2017
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    EKX
    PMA / PMN Number
    K990682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONSOLE IS RUNNING TO MANUFACTURER'S SPECIFICATIONS AND FUNCTIONING PROPERLY. MICRO-MOTOR HAS BEEN DAMAGED WITH THE CASING CRACKING ON THE INSIDE. F16R IS OPERATING TO MANUFACTURER'S SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION HAS CAUSED FILE SEPARATION. 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, THIS 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 DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED 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 X-SMART ENDO MOTOR WAS "GOING TOO FAST"; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833586 X-SMART ENDO MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED EKX DENTSPLY TULSA DENTAL SPECIALTIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1