BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 5837830 · Received August 1, 2016

    Report

    Report Number
    1723170-2016-01855
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    October 7, 2015
    Report Date
    August 1, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE REP REPLACED ROTOR MOTION CONTROLLER. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL ISSUE WITH THE RETURNED ROTOR MOTION CONTROL BOX. INSTALLED ROTOR CONTROL BOX IN TEST SYSTEM. INITIALLY, CONTROL BOX PERFORMED AS EXPECTED, ALLOWING ACQUISITION OF 3D SPIN NO LESS THAN 5 TIMES. 3 HOURS AFTER INSTALL, DURING 3D SPIN PREPARATION, IT WAS NOTED THE ROTOR WAS NOT SPINNING IN PREPARATION, AND SYSTEM DID NOT PROCEED OUT OF 3D SPIN PREPARATION. ROTOR BOX COMMUNICATED IN GALIL TERMINAL, ALLOWED DOWNLOAD OF FIRMWARE, HOWEVER SYSTEM WOULD NOT HOME DURING MOTION CALIBRATION. AT POWER CYCLE, MOTION BAR ON PENDANT INDICATED COLLIMATOR INITIALIZATION ERROR. THE REPORTED EVENT WAS CONFIRMED. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA N(B)(4)DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (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 SITE REPRESENTATIVE REPORTED THAT THE SITE WAS UNABLE TO ACQUIRE PRE-OP NAVIGATED 3D SPIN DURING A SPINAL FUSION PROCEDURE. THEY WERE ABLE TO ACQUIRE 2D IMAGES WITHOUT ISSUE, THE SYSTEM THEN TRANSITIONED INTO 3D MODE AND THEN WOULD SHOW ERROR MESSAGE "3D MODE DISABLED" AFTER MOST OF THE PROGRESS BAR WAS COMPLETED. THE SITE REBOOTED TWICE WITH NO RESOLUTION. THE PROGRESS BAR WOULD SHOW 90% OR SO COMPLETED ACQUISITION AND THEN SHOW ERROR MESSAGE. THE STEALTH COORDINATOR CONFIRMED THAT THE ACQUIRE SCAN PAGE SAID "READY TO ACQUIRE SPIN" AND THAT THE CAMERA WAS SEEING BOTH THE SPINE REFERENCE AND THE IMAGING SYSTEM TRACKER IN THE TRACKING WINDOW. THE SURGEON CHOSE TO DISCONTINUE THE USE OF THE IMAGING SYSTEM AND NAVIGATION SYSTEM, AND PROCEEDED USING A C-ARM. THERE WAS NO REPORTED IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489944 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