BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOLIBRI IMAGE GUIDED SURGERY SYSTEM

    MDR report key: 1899203 · Received October 29, 2010

    Report

    Report Number
    8043933-2010-00015
    Event Type
    Other
    Date Received
    October 29, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K042391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE HAS BEEN NO PATIENT INJURY NOR ANY EVENT REPORTED BY ANY HOSPITAL TO BRAINLAB, A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED. TECHNICAL DETAILS: ACCORDING TO THE SUPPLIER, THE POTENTIAL FAILURE MANIFESTS ITSELF IN ONE OF TWO POSSIBLE WAYS: THE SPECTRA CAMERA STOPS TRACKING, THUS NAVIGATION IS NO LONGER POSSIBLE. IN A MORE UNLIKELY SCENARIO, THE SPECTRA CAMERA MIGHT RETURN DATA WITH ERRORS THAT EXCEED THE PUBLISHED SPECIFICATIONS FOR THE SPECTRA CAMERA. THIS INCORRECT DATA COULD CAUSE RANDOM AND SIGNIFICANT NAVIGATION INACCURACIES. BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS: CUSTOMERS WITH A POTENTIALLY AFFECTED KOLIBRI SPECTRA CAMERA KIT INSTALLED RECEIVE A PRODUCT NOTIFICATION INFORMATION. BRAINLAB WILL REPLACE THE ACCORDING DEVICE COMPONENT FOR THESE CUSTOMERS. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING POTENTIAL EFFECT HAS BEEN COMMUNICATED TO BRAINLAB BY THE SUPPLIER OF THE SPECTRA CAMERAS ASSEMBLED WITHIN THE BRAINLAB KOLIBRI SPECTRA CAMERA KIT: ACCORDING TO THE SUPPLIER, THERE EXISTS A SMALL PROBABILITY THAT SPECIFIC SPECTRA CAMERAS MAY RETURN INCORRECT DATA. IF A SPECTRA CAMERA ASSEMBLED WITHIN THE BRAINLAB KOLIBRI SPECTRA CAMERA KIT WOULD RETURN SUCH INCORRECT DATA, NAVIGATION INACCURACIES OF SEVERAL MILLIMETERS COULD RANDOMLY RESULT DEPENDING ON THE NAVIGATED INSTRUMENT AND ITS POSITION TO THE CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOLIBRI IMAGE GUIDED SURGERY SYSTEM IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT HAW BRAINLAB AG 2.0

    Patients

    Seq Age Sex Outcome Treatment
    1