BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGN CART 9735665 STEALTH S8 PREMIUM

    MDR report key: 8316221 · Received February 7, 2019

    Report

    Report Number
    1723170-2019-00582
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 17, 2019
    Report Date
    March 26, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE POE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE POE WAS TESTED FOR 144 HOURS AND POWER TO THE CAMERA WAS NEVER INTERRUPTED. THE LED WAS GREEN THROUGH THE ENTIRE LENGTH OF TESTING. THERE WAS NO FAILURE FOUND WITH THE POE. 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. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE POWER CORD THAT POWERS THE CAMERA WAS DEFECTIVE. THE POWER CORD FROM THE COMPUTER TO ETHERNET POWER BOX WHICH RUNS THE CAMERA WAS REPLACED. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT WHILE INSTALLING THE SYSTEM, THE CAMERA HAD NO LIGHTS, IT DID NOT BEEP WHEN THE SYSTEM BOOTED AND THE LASER WAS NOT WORKING. THE MEDTRONIC REPRESENTATIVE (MR) LOOKED AT THE POE INJECTOR AND STATED THAT THERE WAS NO GREEN LIGHT. THE MR ALSO STATED THAT THERE WAS NO GREEN LIGHT ON THE SWITCH FROM THE CABLE THAT GOES TO THE POE INJECTOR TO THE SWITCH. THE MR RESEATED THE POWER CABLE ON THE POE INJECTOR THAT COMES FROM THE UNINTERRUPTIBLE POWER SUPPLY (UPS). THERE WAS STILL NO GREEN LIGHT ON THE POE INJECTOR. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. THE MR REPLACED THE POE ANS THE CAMERA DID NOT FUNCTION. HE SAID THAT THERE WERE NO LIGHTS ON THE POE OR ON THE PORT WHEN PLUGGED INTO THE O-RING. HOWEVER, WHEN HE SWAPPED PORTS ON THE O-RING WITH ANOTHER CABLE, THE LIGHT FOR THE PORT ON THE POE STARTED FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109977 SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1