BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 STEALTHSTATION NAVIGATION SYSTEM

    MDR report key: 10712493 · Received October 21, 2020

    Report

    Report Number
    1723170-2020-02763
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 21, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE NOT AVAILABLE FROM THE SITE. PATIENT SEX NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: J M KWAK, J H LEE, J KIM, J M CHOO, S. W. CHO. STEREOTACTIC PELVIC NAVIGATION SURGERY FOR RECURRENT RECTAL CANCER. INT J CARS (2020) 15 (SUPPL 1):S1-S214 PURPOSE STEREOTACTIC NAVIGATION IS USEFUL FOR LOCALIZING, TARGETING, AND GUIDING SURGICAL PROCEDURES WHEN A TARGET CANNOT BE SEEN DIRECTLY [1]. IT HAS BEEN AN ESTABLISHED TECHNOLOGY IN SEVERAL SURGICAL AND INTERVENTIONAL RADIOLOGICAL FIELDS. LIKE NEURONAVIGATION SURGERY, STEREOTACTIC NAVIGATION FOR PELVIC SURGERY IS FEASIBLE SINCE THE SOFT TISSUE ORGANS ARE CONFINED TO THE BONY PELVIS, AND OTHER IMPORTANT ANATOMICAL STRUCTURES ARE RELATIVELY FIXED TO, WHERE WELL DEFINED LANDMARKS, AND A RIGID REGISTRATION ARE AVAILABLE [1, 2]. ON THE OTHER HAND, PELVIC SURGERY IS TECHNICALLY DIFFICULT, AND THERE IS A HIGH RISK OF UNEXPECTED COMPLICATIONS SUCH AS MAJOR VESSEL INJURY AND URETER INJURY, ESPECIALLY DURING MINIMALLY INVASIVE SURGERY, WHICH HAS LACK OF TACTILE FEEDBACK. THE AIM OF THIS STUDY WAS TO APPLY STEREOTACTIC NAVIGATION FOR RECURRENT RECTAL CANCER CASES AND EVALUATE CLINICAL FEASIBILITY AND USEFULNESS BY THE CONCEPT OF ENHANCING SURGEON¿S SPATIAL AWARENESS AND ELIMINATING MUCH OF GUESSWORK. METHODS: PREOPERATIVE COMPUTER TOMOGRAPHY SCANS WERE USED FOR IMAGE DATA. BEFORE IMAGE ACQUISITION, 6¿8 SKIN FIDUCIALS WERE ATTACHED ALONG THE INGUINAL LIGAMENT AND THE PUBIC BONE. A STEALTH STATION S8 OPTICAL NAVIGATION SYSTEM (MEDTRONIC, MINNEAPOLIS, MN) WAS USED WITH CRANIAL SOFTWARE FOR THE STUDY. PATIENT LIED ON THE BEAN BAG TO MINIMIZE SLIDING MOVEMENT DURING POSITION CHANGE, AND A PATIENT TRACKER WAS MOUNTED ON THE OPERATING TABLE. AFTER PREOPERATIVE CT SCAN IMAGES WERE LOADED INTO THE SYSTEM, AND VERIFIED TO MEET THE MINIMUM SYSTEM REQUIREMENT, EACH POINT OF SKIN FIDUCIALS WERE LOCALIZED IN IMAGE SPACE WITH A REGISTRATION POINTER TO COMPLETE PATIENT-TO-IMAGE PAIRED POINT REGISTRATION. THE INSTRUMENT TRACKER WAS MOUNTED ON THE DISTAL SHAFT OF LAPAROSCOPIC INSTRUMENT AND CALIBRATED FOR INSTRUMENT TRACKING. RESULTS FROM DECEMBER 2018 TO NOVEMBER 2019, WE EXPERIENCED THREE CASES OF PELVIC RECURRENCE AFTER RECTAL CANCER SURGERY AND PERFORMED MINIMALLY INVASIVE SURGERY UNDER THE REAL TIME 3 DIMENSIONAL IMAGE GUIDANCE. THE NUMBERS OF USED SKIN FIDUCIALS WERE 8, 8, AND 6 IN EACH CASE, AND THE REGISTRATION ERROR WERE 3.4 MM, 3.2 MM, AND 4.2 MM, RESPECTIVELY (FIG. 1). TOTAL SETUP TIME FOR NAVIGATION SURGERY WAS LESS THAN 30 MIN IN ALL CASES. STEREOTACTIC NAVIGATION GUIDANCE CONTRIBUTED TO BETTER LOCALIZATION OF THE TUMOR. IT ENABLED SURGEON TO PERFORM HIS PROCEDURE WITH BETTER SPATIAL AWARENESS, AND MINIMIZE GUESSING OF SURROUNDING ANATOMY (FIG. 2). NO INTRAOPERATIVE MAJOR COMPLICATION WAS NOTED. CONCLUSION APPLICATION OF CURRENTLY AVAILABLE STEREOTACTIC NAVIGATION SYSTEM SEEMS TO BE FEASIBLE WITH SATISFACTORY ACCURACY IN RECURRENT RECTAL CANCER IN A PELVIC CAVITY BY TARGETING PELVIC AND RETROPERITONEAL STRUCTURES. PATIENT-TAILORED IMAGE-GUIDED NAVIGATION SURGERY ESPECIALLY FOR CHALLENGING CASES WILL ENHANCE SURGICAL QUALITY AND PATIENT SAFETY. REPORTED EVENTS: THREE PROCEDURES WERE NOTED TO HAVE INACCURATE PATIENT REGISTRATION AS THE REGISTRATION ERROR WAS >2MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179402 S8 STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1