BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTORVISION CRANIAL/ENT

    MDR report key: 1790955 · Received August 4, 2010

    Report

    Report Number
    8043933-2010-00012
    Event Type
    Other
    Date Received
    August 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K023651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL: THE CASE WAS CHANGED TO OPEN CRANIOTOMY DURING THE SAME SURGERY, WITH SATISFACTORY CLINICAL OUTCOME. NEVERTHELESS, A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED FOR THIS EVENT. BRAINLAB DETERMINED THAT THE NAVIGATION INACCURACY OCCURRED DUE TO A NO LONGER RIGID INTERFACE FOR THE BRAINLAB REFERENCE STAR ON THE NON-BRAINLAB PATIENT HEAD FIXATION SYSTEM, WHICH WAS NOT RECOGNIZED BY THE USER. THE MANUFACTURER OF THAT NON-BRAINLAB HEAD FIXATION SYSTEM HAS BEEN INFORMED. ACCORDING BRAINLAB MEASURES ARE IN PLACE FOR THE BRAINLAB DEVICE IN QUESTION IN ORDER TO MINIMIZE THE RISK AS FAR AS REASONABLY POSSIBLE. THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT. CORRECTIVE AND PREVENTATIVE ACTIONS: THE NON-BRAINLAB DEVICE IN QUESTION HAS BEEN EXCHANGED AT THIS HOSPITAL. 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 POSSIBLE. THERE ARE NO CORRECTIVE AND PREVENTATIVE 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 AFTER 5 ATTEMPTS. THE USER VERIFIED WITH AN MRI SCAN THAT THE ACTUAL APPLIED TRAJECTORY DIFFERED FROM THE PLANNED, INTENDED TRAJECTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTORVISION CRANIAL/ENT IMAGE GUIDED SURGERY SYSTEM, CAS HAW BRAINLAB AG 22040E

    Patients

    Seq Age Sex Outcome Treatment
    1