BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATION SOFTWARE CRANIAL ESSENTIAL

    MDR report key: 2171475 · Received June 30, 2011

    Report

    Report Number
    8043933-2011-00010
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K082060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE HAS BEEN NO ADVERSE EFFECT REPORTED BY THIS OR ANY OTHER HOSPITAL REGARDING THIS SPECIFIC ISSUE, A RISK TO PT'S HEALTH COULD NOT BE EXCLUDED. BRAINLAB'S INVESTIGATION HAS SHOWN THAT THERE IS AN ERROR FOR A SPECIFIC FEATURE IN SPECIFIC BRAINLAB CRANIAL/ENT NAVIGATION SOFTWARE VERSIONS. IN THE SURFACE MATCHING REGISTRATION DIALOGUE, IF "LAST SOLUTION" AFTER ACQUISITION OF ADD'L REGISTRATION POINTS IS SELECTED, THE SOFTWARE STORES A DIFFERENT REGISTRATION THAN THE ONE DISPLAYED TO THE USER FOR VERIFICATION. PLEASE REFER TO MEDWATCH REPORT # 8043933-2011-00008, DATED JUNE 9, 2011 INCLUDING THE 21 CFR 806 RELEVANT INFO FOR TECHNICAL DETAILS REGARDING THIS ISSUE. FOR BRAINLAB CORRECTIVE ACTIONS, PLEASE REFER TO MEDWATCH REPORT # 8043933-2011-00008, DATED JUNE 9, 2011 INCLUDING THE 21 CFR 806 RELEVANT INFO. THIS SPECIFIC CUSTOMER WAS ALREADY REGARDED FOR THE CORRECTIVE ACTIONS AS DESCRIBED IN MEDWATCH REPORT # 8043933-2011-00008, WHICH ARE THE CORRECTIVE ACTIONS ALSO FOR THIS SPECIFIC EVENT. THIS EVENT AT THIS SPECIFIC HOSPITAL OCCURRED BEFORE INITIATION OF DISTRIBUTION OF THE FIELD SAFETY NOTICE / PRODUCT NOTIFICATION. THIS SPECIFIC CUSTOMER HAS BEEN PROVIDED WITH THE ACCORDING FIELD SAFETY NOTICE / PRODUCT NOTIFICATION UPON ITS AVAILABILITY.

    Description of Event or Problem · 1

    AFTER THE USER COMPLETED THE PT REGISTRATION IN ORDER TO USE THE BRAINLAB NAVIGATION DEVICE FOR A CRANIAL SURGERY, THE USER DETERMINED THAT THE ACCURACY OF THE BRAINLAB NAVIGATION WAS NOT AS DESIRED. THE USER DECIDED, BEFORE PERFORMING THE INCISION FOR THIS SURGERY, TO CONTINUE WITH THIS SURGERY W/O THE AID OF THE BRAINLAB NAVIGATION DEVICE. ACCORDING TO THE HOSPITAL, THERE WAS NO NEGATIVE CLINICAL EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATION SOFTWARE CRANIAL ESSENTIAL IMAGE GUIDED SURGERY SYSTEM, CAS HAW BRAINLAB AG 22207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other