BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISAO®

    MDR report key: 4140868 · Received October 3, 2014

    Report

    Report Number
    1045254-2014-00240
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE HAS HEAT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620336 VISAO® DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 3334800 205665832

    Patients

    Seq Age Sex Outcome Treatment
    1