BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE VIEWING WAND

    MDR report key: 34354 · Received July 17, 1996

    Report

    Report Number
    1037831-1996-00007
    Event Type
    Malfunction
    Date Received
    July 17, 1996
    Date of Event
    June 26, 1996
    Report Date
    July 15, 1996
    Manufacturer
    ISG TECHNOLOGIES, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE VIEWING WAND, IT WAS DISCOVERED THAT THE TRAJECTORY AND PERPENDICULAR VIEWS DO NOT UPDATE PROPERLY WHILE THE SOFTWARE IS IN THE FROZEN MODE. AFTER THE SURGEON DEFINES THE TRAJECTORY WHILE IN THE ACTIVE MODE, THE SCREEN IS THEN FROZEN. THE OPERATOR CLICKS ON THE TARGET TO DETERMINE THE DISTANCE FROM THE TIP OF THE PROBE TO THE FROZEN POINT. IN THIS INSTANCE, BOTH THE IMAGE TRAY AND THE NUMERICAL DISTANCE VALUE APPEAR TO BE TWICE THE VALUE OF THE INITIAL CHOSEN ANATOMICAL POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE VIEWING WAND INTERACTIVE IMAGE-GUIDED SYSTEM LLZ ISG TECHNOLOGIES, INC. VERSION 2.04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other