BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINLAB CRANIAL NAVIGATION SYSTEM

    MDR report key: 3077768 · Received April 23, 2013

    Report

    Report Number
    8043933-2013-00012
    Event Type
    Other
    Date Received
    April 23, 2013
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K092467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NONE OF THE COMPLAINTS RECEIVED FROM THIS CUSTOMER REGARDING THE ACCURACY OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM, AN INJURY OF A PT HAS BEEN REPORTED TO BRAINLAB. IF THE POTENTIAL INACCURACIES WOULD OCCUR AND WOULD NOT BE DETECTED BY USER VERIFICATION AS DESCRIBED IN THE USER MANUAL, A RISK TO PT HEALTH CANNOT BE EXCLUDED. FOR FURTHER DETAILS PLEASE REFER TO ATTACHED PRODUCT NOTIFICATION LETTER CAPA-(B)(4). THIS ISSUE HAS BEEN DETECTED BY A BRAINLAB REPRESENTATIVE DURING TESTING AT THE FOLLOWING SITE: (B)(6). BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS: EXISTING POTENTIALLY AFFECTED CUSTOMERS RECEIVE A PRODUCT NOTIFICATION LETTER. THESE CUSTOMERS RECEIVE A SUPPLEMENT TO THE INSTRUCTIONS FOR USE REGARDING THE BRAINLAB CRANIAL NAVIGATION SYSTEM IN HARDCOPY VERSION AS AN AMENDMENT TO THEIR CURRENT USER MANUALS. TENTATIVE PLANNED TIMELINE FOR AVAILABILITY: JUNE 2013.

    Description of Event or Problem · 1

    A BRAINLAB REPRESENTATIVE PERFORMED NON-CLINICAL TESTS WITH THE BRAINLAB CRANIAL NAVIGATION SYSTEM AT A HOSPITAL IN (B)(6), TO FURTHER INVESTIGATE CUSTOMER COMPLAINTS FROM THIS SITE REGARDING SYSTEM ACCURACY. THE RESULTS OF THESE TESTS AND FURTHER INVESTIGATION HAVE SHOWN THAT, WHEN USING THE BRAINLAB CRANIAL NAVIGATION SYSTEM, THE FOLLOWING MAY HAVE A SIGNIFICANT EFFECT ON THE OVERALL NAVIGATION ACCURACY: LARGE DISTANCE BETWEEN REFERENCE ARRAY AND REGION OF INTEREST. MAJOR CHANGES OF THE CAMERA POSITION RELATIVE TO THE REFERENCE ARRAY DURING THE PROCEDURE. THOSE INSTANCES COULD POTENTIALLY INTENSIFY SMALL INACCURACIES ARISING FROM INDIVIDUAL STEPS OF THE COMPLEX NAVIGATION PROCEDURE. IN THE WORST CASE SCENARIO, THESE INACCURACIES MAY CAUSE AN INACCURATE DISPLAY OF INSTRUMENTS BY THE NAVIGATION SYSTEM, COMPARED TO THE ACTUAL PT ANATOMY. FOR NONE OF THE COMPLAINTS RECEIVED FROM THIS CUSTOMER REGARDING THE ACCURACY OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM, AN INJURY OF A PT HAS BEEN REPORTED TO BRAINLAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173776 BRAINLAB CRANIAL NAVIGATION SYSTEM IMAGE GUIDED SURGERY SYSTEM / STEREOT. HAW BRAINLAB AG SEE CUSTOMER LIST

    Patients

    Seq Age Sex Outcome Treatment
    1 Other