BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISAO®

    MDR report key: 4200437 · Received October 24, 2014

    Report

    Report Number
    1045254-2014-00269
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT INSPECTION DETERMINED THAT THIS HANDPIECE GOT HOT AFTER 30 SECONDS. THE NOSE'S TEMPERATURE WAS 57.8 DEGREES C, THE MIDDLE WAS 25.1 DEGREES C, AND THE REAR WAS 25 DEGREES C. IT WAS ALSO NOISY WHEN RUNNING. THE FULL EVALUATION HAS NOT BEEN COMPLETED AT THIS TIME. METHOD: TEMPERATURE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OTOLOGIC SURGERY, THE HANDPIECE GOT HOT TO THE TOUCH WITHIN 1 MINUTE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678845 VISAO® DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 3334800 205317262

    Patients

    Seq Age Sex Outcome Treatment
    1