BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVIGATION SOFTWARE CRANIAL UNLIMITED

    MDR report key: 2040825 · Received March 30, 2011

    Report

    Report Number
    8043933-2011-00005
    Event Type
    Death
    Date Received
    March 30, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 2, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K082060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL VERBALLY INFORMED BRAINLAB ON (B)(6) 2011 THAT THE PT IN QUESTION HAD DIED, AND ON (B)(6) 2011 THAT THE AGE OF THE PT WOULD BE BETWEEN (B)(6). BRAINLAB'S VISIT TO THIS HOSPITAL ON (B)(6) 2011 TO INVESTIGATE THE DEVICE AND USER WORKFLOW FOR THIS CASE, IN COOPERATION WITH THE HOSPITAL, DID NOT REVEAL ANY INDICATION OF A MALFUNCTION OR A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE. BRAINLAB FOUND THAT THE WORKFLOW FOR THIS CASE DID CONTAIN USE OF A HARDWARE COMBINATION (NON-BRAINLAB PT HEAD FIXATION NOT COMPATIBLE WITH USED BRAINLAB REFERENCE ARRAY CLAMP) AND FURTHER STEPS OF THE USE OF THE DEVICE (DRAPING OF THE REFERENCE ARRAY) THAT WERE NOT AS INTENDED BY BRAINLAB. CORRECTIVE AND PREVENTIVE ACTIONS: THE USERS AT THIS HOSPITAL INVOLVED IN THIS EVENT HAVE ALREADY BEEN VERBALLY REMINDED REGARDING THE CORRECT USE OF THE BRAINLAB DEVICE DURING BRAINLAB'S VISIT TO THIS HOSPITAL ON (B)(6) 2011. BRAINLAB INTENDS TO OFFER THE USERS OF THE BRAINLAB DEVICE IN QUESTION AT THIS HOSPITAL ADDITIONAL TRAINING REGARDING THE USE OF THE RELEVANT BRAINLAB PRODUCTS AND COMPATIBILITIES FOLLOWING BRAINLAB'S OBSERVATIONS AT THIS SPECIFIC HOSPITAL.

    Description of Event or Problem · 1

    AS INFORMED BY THE HOSPITAL, AN INTRACRANIAL BIOPSY SUPPORTED BY THE BRAINLAB NAVIGATION SYSTEM LED TO A HEMORRHAGE. THE USER VERIFIED WITH AN MRI SCAN AT A LATER POINT OF TIME AFTER THE BIOPSY, THAT THE ACTUAL APPLIED TRAJECTORY DIFFERED FROM THE DESIRED TRAJECTORY.

    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 Death