BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 8140299 · Received December 6, 2018

    Report

    Report Number
    1723170-2018-06108
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 9, 2018
    Report Date
    June 6, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SERIAL NUMBER AND UDI NUMBER UNAVAILABLE. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE (REP) WENT TO THE SITE TO TEST THE EQUIPMENT. THE REP CONNECTED THE SYSTEM'S CAMERA TO THE OTHER MEDTRONIC NAVIGATION SYSTEM ON SITE, AND THE CAMERA POWERED ON WITHOUT ISSUE. AS A RESULT, TWO POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) TO CAMERA COMMUNICATION CABLES WERE SENT TO THE SITE. THE REP REPLACED THE OLD SCU TO CAMERA COMMUNICATION CABLES WITH THESE NEW ONES. THE NAVIGATION 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

    DEVICE EVALUATION: THE INTERNAL POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) TO POSITIONING SENSOR UNIT (PSU) CABLE WAS RETURNED TO MEDTRONIC FOR FURTHER EVALUATION. THE CABLE WAS RETURNED WITH THE FEMALE LEMO CONNECTOR END DISASSEMBLED. AFTER RE-ASSEMBLING THE CONNECTOR, THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. THERE WAS NO PROBLEM FOUND WITH THE INTERNAL SCU TO PSU CABLE. THE EXTERNAL SCU TO PSU CABLE WAS ALSO RETURNED TO MEDTRONIC FOR FURTHER EVALUATION. THE RETURNED CABLE HAD A BENT PIN IN THE STRAIGHT LEMO CONNECTOR. AS IS, THE CABLE WOULD NOT CONNECT TO THE MATING PART. AFTER STRAIGHTENING THE PIN, THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. ANALYSIS DETERMINED THERE WAS A PHYSICAL DAMAGE FAILURE WITH THE EXTERNAL SCU TO PSU CABLE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. (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 DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM¿S CAMERA WAS NOT CONNECTED AFTER 30 MINUTES OF THE SYSTEM BEING ON. NO FAULT LIGHT WAS INDICATED ON THE CAMERA. IT WAS NOTED THAT THE CABLE DID NOT SEEM FRAYED. TO TROUBLESHOOT, A MEDTRONIC REPRESENTATIVE (REP) CHECKED THE NDI TOOLBOX, AND THE POSITIONING SENSOR UNIT (PSU) AND POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) DID NOT SHOW UP. THERE WERE GREEN LIGHTS ON THE CAMERA AND THE WIRES FROM THE CAMERA TO THE COMPUTER DID NOT LOOK DAMAGED. THE REP CHECKED THE SCU AND WHEN WIGGLING THE CABLE THAT CONNECTS FROM THE SCU TO THE EXTERNAL CABLE, THE REP WAS ABLE TO SEE THE PSU AND SCU IN THE NDI TOOLBOX FOR A MOMENT. THE ISSUE STILL PERSISTED, HOWEVER, AFTER BYPASSING THE INTERNAL CABLE. THE NDI TOOLBOX SHOWED THE SCU CONNECTED AND THE CAMERA NOT CONNECTED. THERE WERE NO FAULTS IN THE SCU. ON THE SCU THE LOWER LEFT LIGHT WAS SOLID GREEN AND THE RIGHT-SIDE LIGHTS WERE DOUBLE GREEN TO MATCH THE CAMERA, BUT EVERY 10-15 SECONDS THEY WOULD FLASH RED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979689 STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856

    Patients

    Seq Age Sex Outcome Treatment
    1