BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK STRAIGHT ASPIRATOR

    MDR report key: 62450 · Received January 7, 1997

    Report

    Report Number
    53043-1997-00001
    Event Type
    Malfunction
    Date Received
    January 7, 1997
    Date of Event
    December 30, 1996
    Report Date
    December 30, 1996
    Manufacturer
    VISUALIZATION TECHNOLOGY, INC.
    Product Code
    JCX
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER A ONE HOUR PERIOD OF NORMAL USE, THE DEVICE SUDDENLY DEVELOPED AN ERROR OF APPROX 7 MM IN A LATERAL (RIGHT/LEFT) DIRECTION. DURING THE REMAINDER OF THE PROCEDURE THE SURGEON RECHECKED THE DEVICE ACCURACY AT 5 MINUTE INTERVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTATRAK STRAIGHT ASPIRATOR ASPIRATOR/POINTER JCX VISUALIZATION TECHNOLOGY, INC. NA JAZ6263-1

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other INSTATRAK SYSTEM