BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR EM210 LEGEND STYLUS TOUCH

    MDR report key: 2960756 · Received February 14, 2013

    Report

    Report Number
    1045254-2013-00102
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    ERL
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED: (B)(4) 2013. DRILL PASSED THE VISUAL INSPECTION, ATTACHMENT INSPECTION, DIRECTION <(>&<)> SPEED OF ROTATION TESTS, AND VOLTAGE CHECKS IN INDEXED POSITIONS. DRILL FAILED THE TEMPERATURE TEST. THE MEASURED TEMPERATURE RISE DURING THE EVALUATION WAS 37.7 DEGREES F; THE CRITERIA PER THE XPI STATES THAT THE TEMPERATURE RISE MUST BE LESS THAN OR EQUAL TO 27 DEGREES F. THE HIGHEST DETECTED TEMPERATURE DURING THE EVALUATION WAS 114.4 DEGREES F. CONCLUSION: THE "MOST LIKELY" CAUSE OF THIS EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. METHOD - NO TESTING METHODS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HANDPIECE WAS OVERHEATING/RUNNING HOT/HEATING UP. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65094 MOTOR EM210 LEGEND STYLUS TOUCH DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC EM210 205856168

    Patients

    Seq Age Sex Outcome Treatment
    1