BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5841971 · Received August 2, 2016

    Report

    Report Number
    1723170-2016-01761
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    February 13, 2015
    Report Date
    August 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE REPRESENTATIVE DECLINED TO PROVIDE PATIENT INFORMATION WHEN REQUESTED. A MEDTRONIC REPRESENTATIVE VISITED THE SITE AND CONFIRMED THE REPORTED PROBLEM. SHE RE-HOMED THE SYSTEM AND AFTERWARDS THE LEDS INDICATING TUBE/DETECTOR POSITION ARE NOT LIT. THE LEDS DID LIGHT UP AFTER A SYSTEM REBOOT. A REPLACEMENT COLLIMATOR AND MOTION CONTROL BOX ROTOR WERE SENT TO THE SITE FOR REPLACEMENT. THESE TWO PARTS WERE REPLACED IN THE O-ARM BY A MEDTRONIC FIELD SERVICE ENGINEER ON 2/18/2015, AND RESOLVED THE ISSUE. SYSTEM WAS FULLY FUNCTIONAL AFTER PART REPLACEMENTS. ANALYSIS OF SUSPECT PARTS AS FOLLOWS: COLLIMATOR HAD A JAMMED Y AXIS. WAS ABLE TO FREE UP THE Y AXIS BY FORCING THE L SHAPED BRACKET BACK AND FORTH, WAS ABLE TO PASS INITIALIZATION. INTERMITTENT, UNRELIABLE. ELECTRICAL PROBLEM CAUSED EVENT. MOTION CONTROL BOX ROTOR:CONFIRMED REPORTED PROBLEM "UNABLE TO TAKE IMAGES OR OPEN DOOR". WHEN ROTOR MOTION CONTROL BOX WAS INSTALLED IN THE O-ARM SYSTEM, UNABLE TO TAKE 2D OR 3D IMAGES. ELECTRICAL PROBLEM CAUSED EVENT. TWO OTHER PARTS WERE ALSO SENT TO THE SITE, BUT WERE RETURNED UNUSED OR FULLY FUNCTIONAL AND WERE NOT RELATED TO THE REPORTED EVENT. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (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 RADIOLOGY TECH REPORTED THAT SHE WAS UNABLE TO TAKE A SCOUT IMAGE DURING A SPINAL LUMBAR TRAUMA SURGERY. SHE WAS ABLE TO PERFORM ONE SUCCESSFUL 3D SPIN, BUT WHEN SHE WENT TO TAKE A SCOUT IMAGE THE O-ARM WAS UNRESPONSIVE TO THE BUTTON BEING PRESSED. AFTER RE-BOOTING THE O-ARM SHE ATTEMPTED TO OPEN AND CLOSE THE DOOR. AFTER CLOSING THE DOOR THE O-ARM PENDENT WAS INDICATING THAT THE DOOR WAS STILL OPEN. SHE REBOOTED THE O-ARM WITH THE CABLE, CONNECTING IT TO THE MVS (MOBILE VIEWING STATION), DISCONNECTED. WHEN THE O-ARM BOOTED BACK UP AND THE CABLE RE-PLUGGED THE 2D IMAGE SCREEN APPEARED ON THE O-ARM. WHEN SHE ATTEMPTED TO TAKE ANOTHER SCOUT IMAGE THE O-ARM WAS STILL UNRESPONSIVE. SHE WAS ABLE TO MOVE THE O-ARM IN THE LATERAL DIRECTION. SHE ATTEMPTED TO OPEN THE DOOR AGAIN, THE TUBE AND DETECTOR ROTATED AROUND, AND THEN THE O-ARM SHUTTERED, BUT THE DOOR DID NOT OPEN. THE SURGEON ASKED THAT THE O-ARM IMAGING BE DISCONTINUED FOR THE CASE. O-ARM HAD TO BE OPENED MANUALLY FROM AROUND THE PATIENT. THIS DELAYED SURGERY 30 MINUTES. SURGERY COMPLETED SURGERY WITHOUT USE OF THE O-ARM NAVIGATION AND USED A C-ARM INSTEAD. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492793 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1