BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAVIGATION SOFTWARE CRANIAL UNLIMITED

    MDR report key: 1993388 · Received February 8, 2011

    Report

    Report Number
    8043933-2011-00001
    Event Type
    Other
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    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 DID NOT REPORT OR STATE ANY ADVERSE EFFECT FOR THIS PT. NEVERTHELESS, A RISK TO PT HEALTH COULD NOT BE EXCLUDED FOR THIS EVENT. ACCORDING TO 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 PREVENTATIVE 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. BRAINLAB INTENDS TO REMIND THE USERS IN THIS HOSPITAL OF THE RELEVANT INTRAOPERATIVE ACCURACY CHECKS. THERE ARE NO FURTHER CORRECTIVE AND PREVENTIVE ACTIONS INTENDED BY BRAINLAB AT THIS POINT IN TIME. THE MANUFACTURER OF THE NON-BRAINLAB PT HEAD FIXATION SYSTEM INVOLVED IN THIS CASE HAS BEEN INFORMED BY BRAINLAB.

    Description of Event or Problem · 1

    AS INFORMED BY THE HOSPITAL, ONE OF THE TWO PLANNED INTRACRANIAL BIOPSIES FOR THE SAME PT, SUPPORTED BY THE BRAINLAB NAVIGATION SYSTEM, WAS UNSUCCESSFUL AT THE FIRST ATTEMPT. THE USER VERIFIED WITH AN MRI SCAN THAT THE ACTUAL APPLIED TRAJECTORY DIFFERED FROM THE PLANNED, INTENDED TRAJECTORY FOR THE UNSUCCESSFUL BIOPSY ATTEMPT. THE INITIALLY UNSUCCESSFUL BIOPSY WAS REPEATED DIRECTLY AFTER THE RE-SCAN OF THE PT AND COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATION SOFTWARE CRANIAL UNLIMITED IMAGE GUIDED SURGERY SYSTEM, CAS HAW BRAINLAB AG 22213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other