BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 11530388 · Received March 19, 2021

    Report

    Report Number
    1723170-2021-00732
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    January 23, 2021
    Report Date
    March 19, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE UNIQUE IDENTIFIER WAS NOT AVAILABLE AT THE TIME OF REPORTING. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF REPORTING.

    Description of Event or Problem · 1

    NOV K, V., HRABL EK, L., VALO`EK, J., JABLONSK, J., HOZA, J., KORC KOV, I., HAMPL, M., STEJSKAL, P., HUCKO, C. THE USE OF AN O-ARM IN ENDONASAL ENDOSCOPIC OPERATIONS OF THE SKULL BASE. BMC SURG 21, 58 (2021). HTTPS://DOI.ORG/10.1186/S12893-021-01066-W BACKGROUND: ENDOSCOPIC ENDONASAL TRANSSPHENOIDAL APPROACHES ARE BROADLY USED NOWADAYS FOR A VAST SPECTRUM OF PATHOLOGIES SITED IN THE ANTERIOR AND MIDDLE CRANIAL FOSSA. THE USAGE OF NEURONAVIGATION SYSTEMS (NEURONAVIGATION) IN THESE SURGERIES IS CRUCIAL FOR IMPROVING ORIENTATIONS DEEPLY INSIDE THE SKULL AND INCREASING PATIENT SAFETY. METHODS: THE AIM OF THIS STUDY WAS TO ASSESS THE USE OF OPTICAL NEURONAVIGATION, TOGETHER WITH AN INTRAOPERATIVE O-ARM O2 IMAGING SY STEM, IN A GROUP OF PATIENTS WITH HYPOPHYSEAL DENOMA THAT UNDERWENT A TRANSNASAL TRANSSPHENOIDAL SURGERY, AND CORRELATE THE ACCURACY AND ITS DEVIATION DURING THE NAVIGATIONAL PROCESS AGAINST THE USE OF CONVENTIONAL NEURONAVIGATION THAT USES PREOPERATIVE MRI AND CT SCANS. THE OVERALL GROUP CONSISTED OF SIX PATIENTS, BETWEEN 39 AND 78 YEARS OLD, WITH A DIAGNOSIS OF HYPOPHYSEAL ADENOMA. PATIENTS WERE TREATED WITH AN ENDOSCOPIC TRANSSPHENOIDAL TECHNIQUE AND ALL OF THEM UNDERWENT PREOPERATIVE MRI AND CT SCANS OF THE BRAIN. THESE IMAGES WERE USED IN THE NEURONAVIGATION SYSTEM STEALTHSTATION S7 DURING THE SURGERY, WHERE WE DEFINED TWO BONY ANATOMICAL LANDMARKS, SUCH AS A VOMER OR THE ORIGIN OF AN INTRASPHENOIDAL SEPTUM, IN EACH OPERATED PATIENT. THE TIP OF THE NAVIGATIONAL INSTRUMENT, UNDER ENDOSCOPIC CONTROL, POINTED TO THESE LANDMARKS AND THE DISTANCE BETWEEN THE TIP AND THE BONY STRUCTURE WAS MEASURED ON THE NEURONAVIGATION SYSTEM. AFTERWARDS, INTRAOPERATIVE 3D X-RAY IMAGING WAS PERFORMED VIA THE MOBILE SYSTEM O-ARM O2 SYSTEM WITH AUTOMATIC TRANSFER INTO THE NAVIGATIONAL SYSTEM. UNDER ENDOSCOPIC GUIDANCE, WE LOCALIZED THE IDENTICAL BONY ANATOMICAL LANDMARKS USED IN THE PREVIOUS MEASUREMENT AND RE-MEASURED THE DISTANCE BETWEEN THE TIP AND BONY LANDMARK IN IMAGES ACQUIRED BY THE O-ARM. THE RESULTS OF BOTH MEASUREMENTS WERE STATISTICALLY COMPARED. RESULTS: THE MEAN ERROR OF ACCURACY DURING CONVENTIONAL NEURONAVIGATION WITH USAGE OF PREOPERATIVE CT AND MRI SCANS WAS 2.65 MM. DURING THE NEURONAVIGATION, WITH UTILIZATION OF INTRAOPERATIVE 3D O-ARM IMAGES, THE MEAN ERROR OF ACCURACY 0 MM. THESE MEAN ERRORS OF ACCURACY (BOTH MEASUREMENT METHODS WERE COMPARED BY NONPARAMETRIC WILCOXON TEST) HAD A STATISTICALLY SIGNIFICANT DIFFERENCE (P = 0.043). CONCLUSIONS: BASED ON THIS PRELIMINARY CLINICAL STUDY, WE CONCLUDE THAT THE O-ARM IS CAPABLE OF PROVIDING INTRAOPERATIVE X-RAY 3D IMAGES IN SUFFICIENT SPATIAL RESOLUTION IN A CLINICALLY FEASIBLE ACQUISITION. THE MEAN ERROR OF ACCURACY DURING INTRAOPERATIVE NAVIGATION, BASED ON 3D O-ARM SCANS AT THE SKULL BASE, IS SIGNIFICANTLY LOWER COMPARED TO THE USAGE OF NAVIGATION USING CONVENTIONAL PRESURGICAL CT AND MRI IMAGES. THIS SUGGESTS THE SUITABILITY OF THIS METHOD FOR UTILIZATION DURING ENDOSCOPIC ENDONASAL SKULL BASE APPROACHES. REPORTED EVENTS: ONE FEMALE PATIENT WHO WAS (B)(6) YEARS OLD WITH MACROADENOMA-NON-FUNCTIONING ONE MALE PATIENT WHO WAS (B)(6) YEARS OLD WITH MICROADENOMA-M. CUSHING. ONE FEMALE PATIENT WHO WAS (B)(6) YEARS OLD WITH MACROADENOMA-NON-FUNCTIONING. ONE MALE PATIENT WHO WAS (B)(6) YEARS OLD WITH MACROADENOMA-ACRO-MEGALY. ONE MALE PATIENT WHO WAS (B)(6) YEARS OLD WITH MACROADENOMA-NON-FUNCTIONING. ONE MALE PATIENT WHO WAS (B)(6) YEARS OLD WITH MACROADENOMA-NON-FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425302 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR