BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 15380684 · Received September 8, 2022

    Report

    Report Number
    1723170-2022-01444
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    June 15, 2022
    Report Date
    September 8, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. 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. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    GONZALEZ, C., URSO, A.D., DALLEMAGNE, B., MUTTER, D. O084¿REAL-TIME INTRAOPERATIVE IMAGE ACQUISITION IN HYBRID OPERATING ROOM FOR ADJUSTING STEREOTACTIC NAVIGATION ACCURACY DURING PELVIC SURGERY. SURGERY ENDOSCOPY 36 (SUPPL 2), 325¿674 (2022). HTTPS://DOI.ORG/10.1 007/S00464-022-09337-0 INTRODUCTION: STEREOTACTIC NAVIGATION SYSTEMS INCLUDE A COMPUTER SYSTEM THAT USES PATIENT IMAGES (E.G., CT OR MRI) TO GUIDE SURGEONS DURING THE PROCEDURE. CONVENTIONALLY, THE ACQUISITION OF THESE IMAGES IS DONE PREPARATORILY SO THEY DO NOT ALWAYS INDICATE THE ACTUAL LOCATION OF EITHER THE PATIENT OR THE LESION DURING THE OPERATION, RESULTING IN NAVIGATION ACCURACY ERRORS. THE REGISTRATION PROCESS ESTABLISHES BASELINE NAVIGATIONAL ACCURACY. FOR THIS REASON, THE ACQUISITION OF REAL-TIME INTRAOPERATIVE IMAGES PRIOR TO REGISTRATION IS A TECHNIQUE THAT COULD INCREASE THE ACCURACY OF NAVIGATION. METHODS AND PROCEDURES: WITH THE AIM OF ANALYZING THE EFFECT OF REAL-TIME INTRAOPERATIVE IMAGE ACQUISITION ON NAVIGATION ACCURACY DURING PELVIC SURGERY, WE PROCEEDED TO COMPARE REGISTRATION ACCURACY (EXPRESSED AS FIDUCIAL REGISTRATION ERROR FRE) AND NAVIGATION ACCURACY (EXPRESSED AS TARGET REGISTRATION ERROR TRE) WITHOUT (ARM 1) AND WITH (ARM 2) THE USE OF AN INTRAOPERATIVE MULTI-AXIS ROBOTIC C-ARM (ARTIS ZEEGO, SIEMENS HEALTHCARE GMBH, GERMANY) IN THE HYBRID OPERATING ROOM. WE USE THE STEALTHSTATION S8 OPTICAL NAVIGATION SYSTEM (MEDTRONIC, MINNEAPOLIS, MN, USA) FOR NAVIGATION. RESULTS: WE INCLUDE 3 ANIMAL MODELS AND 1 HUMAN SPECIMEN. AFTER PERFORMING THE BASELINE ABDOMINOPELVIC SCANNER WITH CUTANEOUS FIDUCIALS, WE PERFORMED THE NAVIGATION PLANNING THROUGH THE IDENTIFICATION OF THE ANATOMICAL LANDMARKS LOCATED AT THE LEVEL OF THE VASCULAR BIFURCATIONS IN THE AORTA AND ILIAC ARTERIES. IN ARM 1, REGISTRATION WAS PERFORMED USING ONLY THE CUTANEOUS FIDUCIALS AS A REFERENCE. IN ARM 2, REGISTRATION WAS PERFORMED USING A FUSION OF THE INTRAOPERATIVE DYNAMIC CT ACQUISITION WITH THE BASELINE SCANNER. WE OBSERVED THAT THE REGISTRATION ACCURACY WAS SUPERIOR IN ARM 2, BOTH IN THE ANIMAL MODEL AND IN THE HUMAN SPECIMEN (FRE: 1 ± 0.1 MM VS. 1.95 ± 0.5 MM). SUBSEQUENTLY, SURGICAL NAVIGATION WAS PERFORMED IN 3 DIFFERENT POSITIONS: 0º, 10º AND 45º. WE IDENTIFIED THE ANATOMICAL LANDMARKS IN EACH OF THESE POSITIONS. SIMILARLY, THE ACCURACY OF NAVIGATION WAS SUPERIOR IN ARM 2, IN BOTH MODELS (TRE: 2 ± 0.7 MM VS. 2.7 ± 1.3 MM). CONCLUSIONS: IN OUR EXPERIMENTAL SETTING, BY ADDING REAL-TIME INTRAOPERATIVE IMAGE ACQUISITION IN THE HYBRID OPERATING ROOM, IT WAS POSSIBLE TO IMPROVE REGISTRATION ACCURACY AND REDUCE NAVIGATION ERRORS DURING MINIMALLY INVASIVE PELVIC SURGERY. REPORTABLE EVENTS: THE ACCURACY OF NAVIGATION WAS SUPERIOR IN ARM 2 THEN ARM 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107903 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown