BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMARK ENDO MOTOR

    MDR report key: 3850708 · Received March 19, 2014

    Report

    Report Number
    2320721-2014-00004
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Report Date
    February 20, 2014
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    EKX
    PMA / PMN Number
    K111078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVALUATION OF THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE THIS ISSUE 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 DEVICE WAS EVALUATED AND FOUND TO HAVE CORRUPTED SOFTWARE. THE SOFTWARE WAS UPDATED AND THE UNIT OPERATED WITHIN SPECIFICATION. THE REPAIRED UNIT WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT A PROMARK ENDO MOTOR WOULD ADJUST THE TORQUE VALUE TO A LOWER RANGE DURING USE, POSSIBLY CAUSING TWO FILES TO SEPARATE; THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164192 PROMARK ENDO MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED EKX DENTSPLY TULSA DENTAL SPECIALTIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1