BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2830575 · Received November 13, 2012

    Report

    Report Number
    1723170-2012-00631
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. RMA ISSUED FOR TOOL INTERFACE UNIT (TIU). REPLACEMENT PART SHIPPED. THE SUSPECT PART WAS RECEIVED ON (B)(4) 2012 BY THE MANUFACTURER. INVESTIGATION FINDS THAT WHEN CONNECTED TO A KNOWN GOOD SYSTEM, THE TIU PERFORMED AS EXPECTED RETURNING GREEN STATUS FOR ALL PORTS. THE TIU PASSED ALL RECEIVING INSPECTION REQUIREMENTS (RIR) TESTING AND WILL RETURN TO SERVICE INVENTORY. COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE TRIA SYSTEM'S CAMERA TRACKS ACTIVE INSTRUMENTS INTERMITTENTLY. THERE ARE RED LIGHTS ON THE TOOL INTERFACE UNIT (TIU) WHEN THE SYSTEM IS BOOTED UP. RE-BOOTING THE SYSTEM INTERMITTENTLY RESOLVES THE ISSUE. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TRIA

    Patients

    Seq Age Sex Outcome Treatment
    1