BEUDAMED
    FDA Adverse Event Other Summary report: N

    VECTORVISION NAVIGATION SOFTWARE CRAINIAL

    MDR report key: 2417616 · Received January 11, 2012

    Report

    Report Number
    8043933-2012-00001
    Event Type
    Other
    Date Received
    January 11, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 15, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K082060
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE THAT THERE WAS NO ADVERSE CLINICAL EFFECT TO THE PT REPORTED BY THIS HOSP FOR THIS SPECIFIC CASE THERE IS NO INDICATION OF A GENERAL QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE, THE CORRESPONDING BRAINLAB MEASURES FOR THE ANTICIPATED POTENTIAL RISK ARE ALREADY IN PLACE, A RISK TO PT HEALTH COULD NOT BE EXCLUDED FOR THIS SPECIFIC CIRCUMSTANCE, SINCE AN ADD'L SURGERY WAS PERFORMED. AFTER REGISTRATION BY THE USER THE BRAINLAB SOFTWARE DID NOT FIND A MATCH THAT WAS AS ACCURATE TO THE PT'S ACTUAL ANATOMY AS DESIRED. THIS SITUATION WAS NOT DETECTED BY THE USER, DESPITE THE CORRESPONDING VERIFICATION FUNCTIONALITIES OF THE NAVIGATION SOFTWARE THAT ARE AVAILABLE. IN ADDITION THE USER DID NOT CALIBRATE THE MICROSCOPE BEFORE ITS USAGE IN COMBINATION WITH THE NAVIGATION AS REQUIRED. THE COMBINATION OF BOTH, THE NON-DETECTED IMPRECISE INITIAL MATCHING AND THE NON-CALIBRATED MICROSCOPE RESULTED IN A NOTICEABLE INACCURACY. THERE IS NO INDICATION OF A GENERAL QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE, CORRESPONDING BRAINLAB MEASURES FOR THE ANTICIPATED POTENTIAL RISK ARE ALREADY IN PLACE. BRAINLAB INTENDS TO OFFER ADD'L TRAINING TO THIS HOSP.

    Description of Event or Problem · 1

    A CRANIAL SURGERY (OPEN CRANIOTOMY) WAS PERFORMED USING THE AID OF THE BRAINLAB NAVIGATION SYS, A RESECTION OF AN ACOUSTIC NEUROMA WAS INTENDED. ACCORDING TO THE HOSP, THE SURGEON: DETECTED IN THE POSTOPERATIVE MR SCANS THAT THE RESULT OF THE SURGERY WAS INSUFFICIENT AND; DECIDED TO PERFORM AN ADD'L SURGERY FOR THIS PT. THERE WAS NO ADVERSE CLINICAL EFFECT TO THE PT REPORTED BY THIS HOSP FOR THIS SPECIFIC CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTORVISION NAVIGATION SOFTWARE CRAINIAL IMAGE GUIDED SURGERY SYSTEM/STEREOT. HAW BRAINLAB AG 22040G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other