BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5843102 · Received August 3, 2016

    Report

    Report Number
    1723170-2016-01622
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    December 7, 2015
    Report Date
    August 3, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. A REPLACEMENT GANTRY MOTION CONTROLLER WAS SHIPPED TO THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE, TO TEST THE EQUIPMENT. WHILE PERFORMING AN IMAGING SYSTEM CHECK-OUT, THE MEDTRONIC REPRESENTATIVE CONFIRMED THAT THE MOTION SCROLL BAR WOULD NOT INITIALIZE. THE GANTRY MOTION WOULD NOT INITIALIZE AND THE STATUS DISPLAYED AS VERIFIED AND NOT HOMED. THE MEDTRONIC REPRESENTATIVE DETERMINED THAT THE GANTRY MOTION CONTROLLER REQUIRED REPLACEMENT. THE MEDTRONIC REPRESENTATIVE PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. THE GANTRY MOTION CONTROLLER WAS RETURNED TO MEDTRONIC FOR ANALYSIS. ON-SITE INVESTIGATION WAS COMPLETED ON THE RETURNED GANTRY MOTION CONTROLLER. A SIMULATED USE TEST WAS PERFORMED. THE TEST WAS UNABLE TO CONFIRM REPORTED "MOTION CONTROLLER WOULD NOT HOME." THE GANTRY MOTION CONTROL BOX WAS INSTALLED ON A TEST SYSTEM, AND IT OPERATED AS EXPECTED ON ALL AXIS AS WELL AS DOOR OPEN/CLOSE. NO FAULT FOUND. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (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, WHILE IN A SPINE PROCEDURE, THE SITE'S IMAGING SYSTEM WOULD NOT ADVANCE FROM STAND ALONE MODE CAUSING THEM TO THE ABILITY TO TAKE A CONFIRMATION SPIN. THE SURGEON DISCONTINUED USE OF THE IMAGING SYSTEM AND OPTED TO PROCEED WITH AN ALTERNATE METHOD TO CONFIRM PLACEMENT. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. WHILE THE CASE WAS IN PROCESS THE SITE REPRESENTATIVE PLACED A CALL TO TECHNICAL SERVICE. WITH TECHNICAL SERVICE'S ASSISTANCE SEVERAL METHODS OF TROUBLE-SHOOTING TOOK PLACE. THE SITE REPRESENTATIVE REBOOTED THE IMAGING SYSTEM THE PENDANT INDICATES THE SYSTEM IS IN STANDALONE MODE AND REQUESTS THE USER CALIBRATE MOTION. SEVERAL ATTEMPTS WERE MADE TO REBOOT THE SYSTEM AS WELL AS DISCONNECTING AND RECONNECTING THE UMBILICAL. A MOTION CALIBRATION WAS PERFORMED AND STATUS DID NOT CHANGE. AN ATTEMPT TO INVALIDATE HOME WAS TRIED AND ANOTHER MOTION CALIBRATION WAS PERFORMED. THE SYSTEM INDICATED GENERATOR AND MOTION AS A GREEN CHECK BUT WAS STILL STUCK IN STANDALONE MODE. THE TROUBLESHOOTING ATTEMPTS DID NOT RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496767 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 68 YR