BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 8832814 · Received July 26, 2019

    Report

    Report Number
    1723170-2019-04246
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 23, 2019
    Report Date
    April 9, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169505742
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733575, SERIAL/LOT #: (B)(4), UDI#: (B)(4); PRODUCT ID: 9733575, SERIAL/LOT #: (B)(4), UDI#: (B)(4); PRODUCT ID: 9733575, SERIAL/LOT #: (B)(4), UDI#: (B)(4); PRODUCT ID: 9733438, SERIAL/LOT #: (B)(4), UDI#: (B)(4). ANALYSIS OF THE RETURNED SENSOR CONTROL UNIT (SCU) FOUND NO FAULT. THE SCU WAS FOUND TO BE FULLY FUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD COMPONENTS. REVIEW OF THE EVENT LOGS CONFIRMED A SERIES OF INSTANCES WHEN THE SENSOR COULD NOT CONNECT. ANALYSIS OF THE RETURNED SYSTEM COMPUTER FOUND NO FAULT. ANALYSIS OF THE RETURNED SCU CABLE CONFIRMED THE REPORTED EVENT. THE PINS WITHIN THE STRAIGHT LEMO CONNECTOR WERE BENT AND TWISTED. THE CABLE WOULD NOT CONNECT WITH A MATING CONNECTOR FOR TESTING. THE CABLE WAS UNUSABLE AS RECEIVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE CAMERA OF THE NAVIGATION SYSTEM WOULD NOT POWER ON. THE REPRESENTATIVE THEN RETURNED TO THE SITE AND REPLACED THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WAS REPLACED TO RESTORE FUNCTIONALITY. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PSU, SCU, AND CABLE WERE RETURNED TO MEDTRONIC FOR ANALYSIS. NO FAILURES WERE FOUND WITH ANY OF THE THREE COMPONENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT AGAIN AS A RESULT OF THE ISSUE RECURRING. THE SCU TO PSU CABLE WAS REPLACED AND THE SCU WAS REPLACED AGAIN. THE SYSTEM THEN PASSED A SYSTEM CHECKOUT. 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. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733575, SERIAL/LOT #: UNK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE PROBLEM WAS ONLY WITH THE SCU AND NOT THE CABLE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE OPTICAL LOCALIZER OF THE NAVIGATION SYSTEM WAS NOT OPERATING. IT WAS NOTED THAT THERE WAS NO CONNECTION WITH THE NAVIGATION SYSTEM AND THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) DID NOT HAVE A CONNECTION SOUND. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. TROUBLESHOOTING FOUND THAT THE CAMERA CABLE WAS DISTORTED AND THAT THE CAMERA WOULD NOT POWER ON. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE PROBLEM WAS ONLY WITH THE SCU AND NOT THE CABLE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS FOUND THAT THE ISSUE RECURRED. IT WAS SUSPECTED THAT THE SCU WAS THE ISSUE AGAIN AS THE SCU THAT REPLACED THE INITIAL ONE WAS A REFURBISHED PART AND MAY NOT HAVE BEEN WORKING AS INTENDED. IT WAS DECIDED TO REPLACE THE PARTS OF THE CIRCUIT INVOLVED (CABLE AND SCU) AGAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS FOUND THAT THE ISSUE RECURRED. IT WAS SUSPECTED THAT THE SCU WAS THE ISSUE AGAIN AS THE SCU THAT REPLACED THE INITIAL ONE WAS A REFURBISHED PART AND MAY NOT HAVE BEEN WORKING AS INTENDED. IT WAS DECIDED TO REPLACE THE PARTS OF THE CIRCUIT INVOLVED (CABLE AND SCU) AGAIN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE OPTICAL LOCALIZER OF THE NAVIGATION SYSTEM WAS NOT OPERATING. IT WAS NOTED THAT THERE WAS NO CONNECTION WITH THE NAVIGATION SYSTEM AND THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) DID NOT HAVE A CONNECTION SOUND. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. TROUBLESHOOTING FOUND THAT THE CAMERA CABLE WAS DISTORTED AND THAT THE CAMERA WOULD NOT POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626173 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00643169505742

    Patients

    Seq Age Sex Outcome Treatment
    1