BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAIN LAB

    MDR report key: 1996585 · Received February 8, 2011

    Report

    Report Number
    1996585
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    BRAIN MAPPING EQUIPMENT FAILED TO PINPOINT THE EXACT LOCATION OF THE TUMOR. THE SYSTEM INDICATED THE NEUROSURGEON WAS THROUGH THE TUMOR WHEN, IN ACTUALITY, HE WAS APPROXIMATELY ONE INCH BELOW THE TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAIN LAB NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW BRAINLAB AG VECTOR VISION 2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NO OTHER THERAPIES