BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK

    MDR report key: 235399 · Received November 17, 1999

    Report

    Report Number
    1225258-1999-00002
    Event Type
    Malfunction
    Date Received
    November 17, 1999
    Date of Event
    March 29, 1999
    Report Date
    August 3, 1999
    Manufacturer
    VISUALIZATION TECHNOLOGY, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER SUCCESSFUL CALIBRATION AND VERIFICATION, IT WAS REPORTED THAT THE ACCURACY OF THE INSTATRAK SYSTEM DURING ROUTINE SINUS SURGERY WAS OFF BY 4MM WHEN LOCALIZING IN THE PATIENT ANATOMY. HOWEVER, THE ACCURACY APPEARS TO BE ACCURATE WITH THE HEADSET. THERE WAS NO REPORTED PATIENT INTERVENTION REQUIRED.

    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