BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 24928046 · Received April 20, 2026

    Report

    Report Number
    1723170-2026-00627
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    December 23, 2022
    Report Date
    April 20, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MICKO, A.S.G., CHO, A., HECK, S., MARIK, W., WOLFSBERGER, S. DOES HIGH-DEFINITION 3-DIMENSIONAL IMAGING IMPROVE ORIENTATION DURING E NDOSCOPIC TRANSSPHENOIDAL SURGERY? A PROSPECTIVE TRIAL. OPERATIVE NEUROSURGERY. 2023. 24(5):P E330-E335. DOI: 10.1227/ONS.0000000000000581 BACKGROUND: ENDOSCOPY HAS EVOLVED AS THE STANDARD VISUALIZATION TOOL FOR ENDONASAL TRANSSPHENOIDAL RESECTION OF SELLAR LESIONS. THE MOST WIDELY USED 2-DIMENSIONAL (2D) ENDOSCOPES HARBOR THE PROBLEM OF LIMITED DEPTH PERCEPTION. THEREFORE, 3-DIMENSIONAL (3D) ENDOSCOPES HAVE BEEN DEVELOPED TO ENABLE DEPTH PERCEPTION THROUGH A STEREOSCOPIC VIEW. OBJECTIVE: TO EVALUATE THE IMPACT OF HIGH-DEFINITION (HD) 2D VS 3D HD ENDOSCOPES ON SPATIAL ORIENTATION WITHIN THE SPHENOID SINUS. METHODS: IN THIS PROSPECTIVE SINGLE-CENTER STUDY, 21 PATIENTS HAVE BEEN INVESTIGATED (2021-2022). ELEVEN STANDARDIZED ANATOMIC LANDMARKS, WHICH WERE PREOPERATIVELY DEFINED ON NEURONAVIGATION IMAGING, WERE INTRAOPERATIVELY TARGETED WITH A NAVIGATION PROBE USING EITHER 2D HD OR 3D HD ENDOSCOPES FOR VISUALIZATION. RESULTS: OVERALL, 3D HD ENDOSCOPES PROVIDED A STATISTICALLY SIGNIFICANT HIGHER ACCURACY OF IDENTIFICATION OF SPHENOID SINUS LANDMARKS (MEDIAN DEVIATION: 5.2 MM VS 4.2 MM, P <(><<)> .001). IN DETAIL: TUBERCULUM SELLAE (3.0 MM VS 4.3 MM, P = .047), MOST ANTERIOR POINT OF SELLA (3.3 MM VS 4.8 MM, P = .049), AND CLIVUS INDENTATION (3.8 MM VS 5.3 MM, P = .035). ANATOMIC VARIATIONS SUCH AS A COMPLEX SPHENOID SINUS CONFIGURATION HAD NO INFLUENCE ON IDENTIFYING SPHENOID SINUS LANDMARKS. CONCLUSION: ACCORDING TO OUR DATA, STEREOSCOPIC 3D HD ENDOSCOPY ENHANCES INTRAOPERATIVE ORIENTATION BY IMPROVED DEPTH PERCEPTION WITHIN THE SPHE NOID SINUS. THIS MAY ADD TO THE SAFETY OF ENDOSCOPIC SKULL BASE PROCEDURES, ESPECIALLY IN EXTENDED APPROACHES AND CASES WITH DISTORTED ANATOMY. REPORTED EVENTS: LARGEST DEVIATION OF A 3D HD (5.1MM) LARGEST DEVIATION OF A 2D HD (4.0-7.6MM)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257423 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male