BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR EM210 LEGEND STYLUS TOUCH

    MDR report key: 3100164 · Received May 8, 2013

    Report

    Report Number
    1045254-2013-00366
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 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

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). EVALUATION SUMMARY: THERE IS NO PRODUCT ANALYSIS AVAILABLE, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED ON (B)(4) 2013. EVALUATION SUMMARY: DURING PRODUCT ANALYSIS THE COMPLAINT FOR EXCESSIVE HEAT WAS UNABLE TO BE CONFIRMED. THE MANUFACTURING INSPECTIONS WERE PERFORMED ON THE DRILL, INCLUDING THE VISUAL/ATTACHMENT INSPECTIONS, TEMPERATURE TEST, ROTATION TEST, AND VOLTAGE READING TESTS. THE HIGHEST DETECTED TEMPERATURE DURING THE TEMPERATURE TEST WAS 94.9 DEGREES F. THE DRILL PASSED ALL INSPECTIONS, INCLUDING THE TEMPERATURE TEST.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE AVAILABLE INFORMATION INDICATES THAT THE USER EXPERIENCED EXCESSIVE HEAT FROM THE HANDPIECE, THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200575 MOTOR EM210 LEGEND STYLUS TOUCH DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. EM210 69819200

    Patients

    Seq Age Sex Outcome Treatment
    1