BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK STRAIGHT ASPIRATOR

    MDR report key: 73257 · Received February 24, 1997

    Report

    Report Number
    1225258-1997-00004
    Event Type
    Malfunction
    Date Received
    February 24, 1997
    Date of Event
    February 18, 1997
    Report Date
    February 24, 1997
    Manufacturer
    VISUALIZATION TECHNOLOGY, INC.
    Product Code
    MGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE ACCURACY WAS SUDDENLY OFF BY SEVERAL MM DURING USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other INSTATRAK SYSTEM