BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOLIBRI IMAGE GUIDED SURGERY SYSTEM

    MDR report key: 1739444 · Received June 25, 2010

    Report

    Report Number
    8043933-2010-00011
    Event Type
    Other
    Date Received
    June 25, 2010
    Report Date
    June 2, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K042391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE HAS BEEN NO PATIENT OR USER INJURY NOR ANY EVENT REPORTED BY ANY HOSPITAL A RISK TO PATIENT OR USER HEALTH COULD NOT BE EXCLUDED. FOR A SPECIFIC BATCH (BATCH #(B)(4)) OF THE CAMERA INTERFACES ((B)(4)). ASSEMBLED WITHIN THE KOLIBRI MOBILE CAMERA STAND ((B)(4)), LONG-TERM RELIABLE FIXATION OF THE CAMERA UNIT CANNOT BE GUARANTEED DUE TO A MANUFACTURING ERROR. BRAINLAB INTENDS THE FOLLOWING CORRECTION ACTIONS: CUSTOMERS WITH A KOLIBRI MOBILE CAMERA STAND ASSEMBLED WITH POTENTIALLY AFFECTED SPECIFIC BATCH OF THE CAMERA INTERFACE RECEIVE A PRODUCT NOTIFICATION INFORMATION. BRAINLAB WILL EXCHANGE THE ACCORDING DEVICE COMPONENT AT NO COST FOR THESE CUSTOMERS WITHIN THE NEXT 6 MONTHS.

    Description of Event or Problem · 1

    BRAINLAB INTERNALLY DETECTED: FOR A SPECIFIC BATCH OF THE CAMERA INTERFACES ASSEMBLED WITHIN THE KOLIBRI MOBILE CAMERA STAND, A LONG-TERM RELIABLE FIXATION OF THE CAMERA UNIT CANNOT BE GUARANTEED DUE TO A MANUFACTURING ERROR. THE CAMERA UNIT WITH A WEIGHT OF APPROXIMATELY 3 KG (APPROX. 6.6 LBS) COULD LOOSEN AND DETACH WHILE MOVING THE CAMERA ARM OR STAND OF THE KOLIBRI NAVIGATION SYSTEM, FOR EXAMPLE DURING USE OR TRANSPORTATION, WHICH COULD POTENTIALLY RESULT IN A SERIOUS PATIENT OR USER INJURY.

    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