BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION COMPACT NAVIGATION SYSTEM

    MDR report key: 6910565 · Received October 3, 2017

    Report

    Report Number
    6910565
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 28, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OGR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FEMALE PATIENT WAS SCHEDULED TO UNDERGO A BILATERAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. SHE WAS BROUGHT TO THE OR AND INDUCED WITH GENERAL ANESTHESIA. THE NAVIGATION SYSTEM WAS BROUGHT ONTO THE FIELD AND IT INITIALLY MALFUNCTIONED. THE SURGEON WAS ABLE TO SUCCESSFUL REGISTER THE PATIENT'S ANATOMY TO THE PRE-OPERATIVE CT SCAN, BUT WAS UNABLE TO REGISTER THE INSTRUMENTS (SUCTIONS) TO THE SYSTEM. THE TEAM WAS ABLE TO TROUBLE SHOOT THE PROBLEM WITH HELP FROM THE COMPANY VIA PHONE AND WERE ABLE TO GET THE EQUIPMENT TO PROPERLY REGISTER. THE COMPANY REP SUGGESTED THAT THE STAFF POST TROUBLE-SHOOTING INSTRUCTIONS (4 SPECIFIC ACTIONS) IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690730 FUSION COMPACT NAVIGATION SYSTEM EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT OGR MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NO