BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 SYSTEM

    MDR report key: 11656236 · Received April 13, 2021

    Report

    Report Number
    1723170-2021-00979
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    April 9, 2021
    Report Date
    May 4, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H2/H3/H6: THE SYSTEM WAS SERVICED IN THE FIELD AND THE CAMERA WAS REPLACED. THE SYSTEM PASSED ALL TESTS AND WAS PERFORMING AS INTENDED. CODES B01, C02 AND D02 ARE APPLICABLE. D9/H2/H3/H6: THE CAMERA WAS RETURNED AND ANALYZED. THE RETURNED CAMERA/POSITION SENSOR UNIT (PSU) POWERED UP ON THE TEST BENCH WITHOUT ISSUE BUT A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY DATING BACK TO OCT 2018. THERE WAS ALSO A BUMP DETECTED ON APR 9, 2021. OTHERWISE, THE PSU PASSED AN ACCURACY TEST AT .23 MM WITH A PASSING THRESHOLD OF .25 MM. CODES B01, C02 AND D02 ARE APPLICABLE. H2: ADDITIONAL INFORMATION RECEIVED UPON RETURN OF THE CAMERA. THE LOT NUMBER FOR PRODUCT 9735821 IS P901289. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 735821, SERIAL/LOT #: UNK.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE SETTING UP FOR A CASE, THE SYSTEM WAS TURNED ON AND THE CAMERA WAS SHOWING THAT THE LOCALIZER WAS DISCONNECTED. THE CAMERA CART MONITOR WAS ON AND RECEIVING A PICTURE FROM THE PCOIP ZERO CLIENT. THEY TRIED TO REBOOT WITH NO RESOLUTION. THE CAMERA HAD WORKED PREVIOUSLY THAT DAY. LIKELY THE NETWORK CABLE CHAIN FROM THE POE TO THE CAMERA GOT DAMAGED. THERE WAS NO PATIENT PRESENT. ADDITIONAL INFORMATION NOTED THAT THE REPRESENTATIVE HAND PICKED UP THE CAMERA FOR THIS CASE WHILE THE CABLE CHAIN WAS BEING KITTED. SHE ARRIVED ON SITE AND WAS ABLE TO CONFIRM THAT THE CAMERA WAS THE ISSUE BY SWAPPING THE BAD CAMERA WITH A KNOWN GOOD CAMERA FROM ANOTHER SYSTEM. THE NEW CAMERA WAS THEN INSTALLED ON THE ORIGINAL SYSTEM AND FUNCTIONED AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553300 STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 "SEE H10...."