BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK

    MDR report key: 233530 · Received November 17, 1999

    Report

    Report Number
    1225258-1999-00001
    Event Type
    Malfunction
    Date Received
    November 17, 1999
    Date of Event
    June 29, 1999
    Report Date
    July 21, 1999
    Manufacturer
    VISUALIZATION TECHNOLOGY, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DOCTOR REPORTED THE VISUAL ACCURANCY OF TRACKING WHILE USING THE INSTATRAK SYSTEM DURING SINUS SURGERY WAS OFF >5MM WHEN TOUCHING ANATOMICAL LANDMARKS. THE DOCTOR DISCOUNTINUED USE OF THE SYSTEM AND THE PATIENT STATUS WAS REPORTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTATRAK IMAGE GUIDED SURGERY DEVICE LLZ VISUALIZATION TECHNOLOGY, INC. 2000 MO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other