BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR EM210 LEGEND STYLUS TOUCH

    MDR report key: 2940234 · Received February 2, 2013

    Report

    Report Number
    1045254-2013-00068
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    January 4, 2013
    Manufacturer
    XOMED MFG JACKSONVILLE
    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

    DEVICE WAS RETURNED (B)(4) 2013. THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE FULL INSPECTION COULD NOT BE PERFORMED; THE DRILL FAILED THE VISUAL INSPECTION DUE TO THE FINGER SWITCH LEVER BEING DETACHED. WITHOUT THE FINGER SWITCH, THE DRILL IS INOPERABLE AND CANNOT BE RUN; THEREFORE, NO OTHER INSPECTIONS COULD BE COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. H6 CODES: THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED. METHOD: NO TESTING METHODS PERFORMED.

    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 THAT A LEGEND STYLUS TOUCH HANDPIECE HEATED UP. THERE WAS NO REPORTED PATIENT OF USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45690 MOTOR EM210 LEGEND STYLUS TOUCH DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL XOMED MFG JACKSONVILLE EM210 68389400

    Patients

    Seq Age Sex Outcome Treatment
    1