BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 5843324 · Received August 3, 2016

    Report

    Report Number
    1723170-2016-01863
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    June 23, 2015
    Report Date
    August 3, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. COMPLETED SYSTEM CHECKOUT WITH NO ISSUES INITIALLY OBSERVED. SOFTWARE LOGS SAVED AND IMAGES CAPTURED. LOGS INDICATED ERRORS ASSOCIATED WITH D:IMAGERS "ERROR UPDATING OFFSET CORRECTION FILE." SHUT SYSTEM DOWN AND RESTATED CONNECTIONS AT (B)(6),CP, MOBILE VIEW STATION (MVS) COMPUTER, AND IMAGE ACQUISITION SYSTEM (IAS) COMPUTER. REMOVED BLUE ETHERNET CONNECTION AT REAR OF MVS PC AND RECONNECTED WITH SYSTEM ON. CORRECTED TIME ON MVS COMPUTER. MOVED SYSTEM TO OR AND IAS REMAINED IN STAND ALONE AFTER UMBILICAL RECONNECT, CT. Q TO RESTART MVS APPLICATION AND REGAINED CONNECTION. REBOOTED BOTH SYSTEMS 2D/3D WITH NO ISSUES. REMOVED UMBILICAL AND RECONNECTED AFTER APPROX. 2 MINUTES WITH GOOD SYSTEM RECONNECT 2D/3D GOOD. SHUT DOWN AND RESTARTED MVS ONLY WITH NAVIGATION SYSTEM CONNECTION REMOVED 2D/3D GOOD. SHUT DOWN AND RESTART IAS ONLY WITH STEALTH CONNECTION REMOVED 2D/3D GOOD. SHUT DOWN MVS AND IAS AND RESTARTED WITH STEALTH CONNECTED 2D/3D GOOD. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE (B)(6) BOX WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE (B)(6) BOX WAS INSTALLED IN THE TEST IMAGING SYSTEM AND RAN WITHOUT ANY ISSUES. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. (B)(4). THIS REVIEW WAS PERFORMED AS A RESULT OF RECENT CHANGES/IMPROVEMENTS TO THE MEDTRONIC NAVIGATION, INC. MEDICAL DEVICE REPORT (MDR) REVIEW PROCESS AND IS FOR NON-ADVERSE EVENT REPORTABLE MALFUNCTIONS WITHIN THE LAST TWO YEARS WHERE THE USE OF THE O-ARM IMAGING SYSTEM WAS ABORTED. THIS PROCESS CHANGE RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY MEDTRONIC NAVIGATION, INC., SINCE APRIL 2016. IT SHOULD BE NOTED THAT THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE REGULATIONS WITHIN OUR PROCESSES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE THE 3D SPIN WAS UNABLE TO BE USED DUE TO DISTORTION. DURING TROUBLESHOOTING THEY TOOK LOCALIZERS AND PRESSED BUTTON FOR 3D. SAW BAR INITIALIZING THE 3D SPIN, BUT IT NEVER SHOWED ANY PROGRESS AND IMAGING SYSTEM NEVER SPUN. MOVED OUT OF A/P POSITION, RELEASED, PUSHED BUTTON AGAIN. MOVED BACK A/P BUT DID NOT EXPOSE. REBOOTED, DID NOT DO LOCALIZER IMAGES SINCE GANTRY HAD NOT MOVED. PRESSED 3D BUTTON AND IT SPUN NORMALLY (HIGH DEF). IMAGES SHOWED UP ON MOBILE VIEW STATION (MVS) BUT WERE DISTORTED/NOT USABLE. AFTER ABOUT A 45 MINUTE DELAY, THE SURGEON CHOSE TO DISCONTINUE USE OF THE IMAGING SYSTEM AND PULLED ANOTHER IMAGING SYSTEM INTO THE ROOM. THE SECOND IMAGING SYSTEM WAS USED TO COMPLETE THE PROCEDURE AS PLANNED. THERE WAS NO REPORTED IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494823 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00028-120

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR