BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR EM210 LEGEND STYLUS TOUCH

    MDR report key: 2940233 · Received February 2, 2013

    Report

    Report Number
    1045254-2013-00067
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    January 4, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    ERL
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    SERIAL #: (B)(4). DEVICE RETURNED: (B)(4) 2013. DEVICE EVALUATION: THE RETURNED DEVICE WAS EVALUATED. THE DRILL PASSED THE VISUAL INSPECTION, THE ATTACHMENT INSPECTION (ABILITY TO LOCK/UNLOCK), DIRECTION OF ROTATION INSPECTION, AND VOLTAGE CHECK. THE DRILL FAILED THE TEMPERATURE TEST AND THE SPEED OF ROTATION TEST. THE HIGHEST DETECTED TEMPERATURE DURING THE TEMPERATURE TEST WAS 113.2 DEG F, WITH A DETECTED 39.9 DEG RISE IN TEMPERATURE DURING THE TEST (DURATION = 5 MINS). DURING THE SPEED OF ROTATION TEST, WHEN THE DRILL WAS SET TO RUN AT 60K RPM, THE MEASURED SPEED OF THE DRILL WAS 56617 RPM, WHICH IS BELOW THE SPECIFIED ACCEPTABLE RANGE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC THAT A LEGEND STYLUS TOUCH HANDPIECE WAS HEATING UP. THERE WAS NO REPORTED PATIENT OR USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45548 MOTOR EM210 LEGEND STYLUS TOUCH DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC INC. EM210 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1