BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9733856 S7 STAFF ASSEMBLED 110V

    MDR report key: 8725000 · Received June 21, 2019

    Report

    Report Number
    1723170-2019-03756
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    June 21, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CART 9733856 S7 STAFF ASSEMBLED 110V (SERIAL #: (B)(4)) FOUND NO FAILURE, AS IT PASSED THE WORK ORDER. ANALYSIS OF THE PSU 9733437 POLARIS SPECTRA (LOT #: P713124) FOUND THAT THERE WAS NO POWER. WHEN CONNECTED TO A KNOWN GOOD SYSTEM, THE PSU WOULD NOT POWER UP. ANALYSIS OF THE CABLE 9733575 EXT SCU TO R/A PSU (LOT #: 151104) FOUND NO FAILURE. THE RETURNED CABLE WAS FOUND TO BE IN GOOD CONDITION AND PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. ANALYSIS OF THE SCU 9733438 POLARIS CAMERA (LOT #: T303881) FOUND NO FAILURE. THE RETURNED SCU WAS FOUND TO BE FULLY FUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD SYSTEM. THE SCU HAD COMMUNICATION WITH THE PSU AND NORMAL TRACKING FOR ALL PORTS. ANALYSIS OF THE CABLE 9733581 RS422 SCU TO I/O HUB (LOT #: 151112) FOUND NO FAILURE. THE RETURNED CABLE WAS FOUND TO BE IN GOOD CONDITION AND PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. PRODUCT EVENT SUMMARY #S7 CAMERA NOT COMMUNICATING. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733581, SERIAL/LOT #: (B)(4). PRODUCT ID: 9733438, SERIAL/LOT #: (B)(4), UDI#: (B)(4). PRODUCT ID: 9733575, SERIAL/LOT #: (B)(4). PRODUCT ID: 9733437, SERIAL/LOT #: (B)(4), UDI#: (B)(4). 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 BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE CAMERA DID NOT CONNECT IN THE SOFTWARE. USER BY-PASSED THE INTERNAL CAMERA CABLE AND RESEATED THE EXTERNAL CAMERA CABLE BUT THE CAMERA DID NOT DISPLAY ANY LIGHTS. THEY BYPASSED THE I/O HUB THEN LOOKED AT THE NDI CONFIGURATION UTILITY WHICH INDICATED SEVERAL ERRORS OF BEING UNABLE TO ESTABLISH CONNECTION TO POSITION SENSOR ON PORT 1. AFTER PLUGGING THE FIREWIRE CABLE BACK INTO THE I/O HUB, FAILED TO CONNECT TO /DEV/TTY/USB0 DISPLAYED. USER RESEATED THE COMMUNICATION CABLE FROM THE SCU TO THE I/O HUB BUT THE ISSUE WAS NOT RESOLVED. SCU DISPLAYED RED AMBER AND TWO GREEN LIGHTS. USB VIEW AND SOUND TEST INDICATED I/O HUB WAS WORKING. SITE WAS UNABLE TO USE NAV FOR THE CASE. THIS OCCURRED INTRA/PERI-OPERATIVELY WITH NO DELAY TO SURGICAL TIME. NAVIGATION WAS ABORTED, BUT THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516547 CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR