BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAVIGATION SOFTWARE CRANIAL UNLIMITED

    MDR report key: 1912826 · Received November 5, 2010

    Report

    Report Number
    8043933-2010-00016
    Event Type
    Other
    Date Received
    November 5, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K082060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPORTS "NEUROLOGICAL DEFICIT" ON THE PATIENT AND LIKELY INCOMPLETE DIAGNOSIS. ACCORDING BRAINLAB MEASURES ARE IN PLACE FOR THE BRAINLAB DEVICE IN QUESTION IN ORDER TO MINIMIZE THE RISK AS FAR AS REASONABLY PRACTICABLE. THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT. THE BRAINLAB DEVICE WORKS ACCORDING TO THE SPECIFICATIONS. CORRECTIVE AND PREVENTIVE ACTIONS: SINCE THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT. ACCORDING BRAINLAB MEASURES ARE IN PLACE FOR THE BRAINLAB DEVICE IN QUESTION IN ORDER TO MINIMIZE THE RISK AS FAR AS REASONABLY PRACTICABLE. THERE ARE NO CORRECTIVE AND PREVENTIVE ACTIONS INTENDED BY BRAINLAB AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    AS INFORMED BY THE HOSPITAL, AN ATTEMPTED INTRACRANIAL BIOPSY SUPPORTED BY THE BRAINLAB NAVIGATION SYSTEM WAS UNSUCCESSFUL. THE USER VERIFIED WITH AN MRI SCAN THAT THE ACTUAL APPLIED TRAJECTORY DIFFERED FROM THE PLANNED, INTENDED TRAJECTORY, AND BRAIN TISSUE WAS EXTRACTED FROM A DIFFERENT LOCATION THAN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATION SOFTWARE CRANIAL UNLIMITED IMAGE GUIDED SURGERY SYSTEM, CAS HAW BRAINLAB AG 22208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other