BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION COMPACT NAVIGATION SYSTEM

    MDR report key: 6910169 · Received October 3, 2017

    Report

    Report Number
    6910169
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 6, 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 WAS SCHEDULED TO UNDERGO A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. SHE WAS BROUGHT TO THE OR AND INDUCED WITH GENERAL ANESTHESIA. SHE WAS PREPPED AND DRAPED AND THE NAVIGATION SYSTEM WAS BROUGHT ONTO THE FIELD, AND DURING THE PROCEDURAL TIMEOUT, IT WAS NOTED THAT THE CT IMAGE GUIDANCE SYSTEM WAS NOT FUNCTIONING PROPERLY. ALL STAFF IN THE ROOM WERE VERY FAMILIAR WITH THE PROCEDURE AND THE EQUIPMENT. THE SURGEON WAS ABLE TO REGISTER THE PATIENT AND WAS ABLE TO VERIFY STRAIGHT SUCTION. HOWEVER, WHEN SHE ATTEMPTED TO USE IT, SHE COULD NOT GET THE TRACING TO WORK AND THE CROSSHAIR CHANGED TO RED - INDICATING A POOR SIGNAL. TROUBLE-SHOOTING WAS ATTEMPTED TO RESTORE FUNCTIONALITY WITH PHONE ASSISTANCE BY MEDTRONIC REP - INCLUDING RE-BOOTING, MOVING PATIENT TRACKER, CHANGING INSTRUMENT TRACKER AND RE-REGISTERING, BUT THIS DID NOT RESOLVE THE PROBLEM. THE STAFF DID NOT AGREE TO MOVE THE EMITTER - BUT STAFF IN THE ROOM FAMILIAR WITH THE EQUIPMENT CONFIRMED THAT THE SETTING WAS GOOD. AFTER APPROXIMATELY AN HOUR DURING WHICH THE PATIENT WAS UNDER ANESTHESIA, THE SURGEON DECIDED TO ABORT THE CASE. THE SURGEON MET WITH THE PATIENT AND EXPLAINED WHAT HAPPENED AND THE PATIENT WAS RE-BOOKED FOR A FEW WEEKS LATER. THE SURGEON REPORTED THIS EVENT TO THE COMPANY. THE OR REPORTED THE EVENT TO RISK MANAGEMENT WHEN THE COMPANY CONTACTED HER. THE EQUIPMENT REPORTEDLY ALSO POSED PROBLEMS FOR 1-3 OTHER SURGEONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691332 FUSION COMPACT NAVIGATION SYSTEM EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT OGR MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other NO