BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK STRAIGHT ASPIRATOR

    MDR report key: 91127 · Received May 12, 1997

    Report

    Report Number
    1225258-1997-00006
    Event Type
    Malfunction
    Date Received
    May 12, 1997
    Date of Event
    May 7, 1997
    Manufacturer
    VISUALIZATION TECHNOLOGY, INC.
    Product Code
    MGI
    Removal / Correction Number
    Z-431-7
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INSTATRAK ACCURACY WAS OFF DURING SURGERY BY 4-8 MM WITH ONE ASPIRATOR, 2-4MM. WITH A SECOND.

    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 71 YR Other