BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 SYSTEM

    MDR report key: 10968682 · Received December 8, 2020

    Report

    Report Number
    1723170-2020-03206
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 18, 2020
    Report Date
    March 4, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169876972
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE MAIN CART TO CAMERA CART CABLE, UNINTERRUPTIBLE POWER SUPPLY (UPS), AND AN ADDITIONAL UPS WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE COMPONENTS WERE FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. CONTINUATION OF D10: PN: 9735787, LN/SN: 0010363696; PN: 9735788, LN/SN: 19070053; PN: 9735772, LN/SN: 190304 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 · 0

    CONTINUATION OF D11: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735737, VERSION #: 1.2.0 H3) THE SOFTWARE TEAM INVESTIGATED THE REPORTED ISSUE AND OBSERVED THAT THERE IS RABBITMQ CONNECTION ERROR AND UPS THROWING ERROR SAYING UNKNOWN STATUS.  BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT A SOFTWARE ANOMALY CONTRIBUTED TO THE REPORTED BEHAVIOR. SOFTWARE APPEARS TO BE WORKING AS DESIGNED. THEY FOUND INSUFFICIENT INFORMATION ON WHAT CAUSED THE REPORTED ISSUE. 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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 9735772, SERIAL/LOT #: (B)(4). PRODUCT ID: 9735788, SERIAL/LOT #: (B)(4). PRODUCT ID: 9735773, SERIAL/LOT #: (B)(4). PRODUCT ID: 9735787, SERIAL/LOT #: (B)(4). PRODUCT ID: 9735771, SERIAL/LOT #: (B)(4). THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. THERE WAS NO POWER GOING TO THE CAMERA CART. THIS WAS OBSERVED IN SELF TEST THAT THERE WAS NO CONNECTION TO THE CAMERA CART FROM THE MAIN CART. THEY REPLACED THE EXTERNAL MAIN TO THE CAMERA CART CABLE AND TESTED THE SYSTEM. THE BATTERIES WERE TESTED ALSO BY UNPLUGGING THE SYSTEM FROM THE WALL FOR OVER 10 MINS AND SYSTEM WAS STILL POWERED ON. HOWEVER, THE SYSTEM POWERED DOWN INTERMITTENTLY AFTER RUNNING FOR 1-2 HRS. THEY REPLACED THE UNINTERRUPTIBLE POWER SUPPLY (UPS) ON THE MAIN AND CAMERA CART. THEY ALSO REPLACED THE UPS BATTERIES, MAIN CART BATTERIES, MAIN CART POWER SUPPLY, CAMERA CART BATTERY AND CAMERA CART UPS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT SEVERAL TIMES THE CAMERA CART POWERED DOWN ON ITS OWN AFTER BEING POWERED UP. THE SITE DIDN'T KNOW IF THE MAIN CART ALSO POWERED DOWN AT THIS TIME. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED ISSUE WAS STILL OCCURRING AFTER REPLACING THE CART TO CART CABLE. IT WAS RECOMMENDED TO THE MANUFACTURER REPRESENTATIVE (REP) TO LEAVE THE SYSTEM ON FOR A FEW HOURS TO SEE HOW LONG IT TAKES THE ISSUE TO OCCUR. THE REP WILL REPLACE THE CAMERA CART UNINTERRUPTIBLE POWER SUPPLY (UPS) TO SEE IF IT RESOLVES THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SITE CONFIRMED THAT THE OUTLET WAS FUNCTIONAL THAT THE SYSTEM WAS PLUGGED INTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435492 STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735667 00643169876972

    Patients

    Seq Age Sex Outcome Treatment
    1