BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6079243 · Received November 4, 2016

    Report

    Report Number
    1723170-2016-03621
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 28, 2014
    Report Date
    November 4, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A SITE REPRESENTATIVE DECLINED TO PROVIDE PATIENT INFORMATION. A MEDTRONIC REPRESENTATIVE INSPECTED THE IMAGING SYSTEM ON-SITE. ON (B)(6) 2014 - DURING SYSTEM CHECKOUT THE X-SAGE COVER WAS SO BENT THAT WHILE TRYING TO DOCK THE GANTRY WOULD NOT DOCK. RE-HOMED THE IMAGING SYSTEM. WAS ABLE TO KNOCK OUT THE X-STAGE COVER TO FIX IT BUT HAVE ORDERED A NEW COVER. FOUND ERRORS ON DOOR OPEN FROM THE GANTRY MOTION CONTROLLER. ALSO FOUND THAT THE POSITIONER CONTROLLER ALSO HAD ISSUES BUT IT WAS LIKELY FROM THE X-STAGE COVER BEING SO BENT THAT THE X MOTION IS STOPPING. ORDERED A NEW GANTRY CONTROLLER AND A NEW X-STAGE COVER. ON (B)(6) 2014 - CHANGED GANTRY MOTION CONTROLLER DUE TO ERRORS NOT LETTING THE SITE OPEN THE DOOR AROUND A PATENT. ALSO CHANGED THE X-STAGE COVER BECAUSE IT WOULD NOT DOCK AFTER MOTIONS BEING RE-HOMED. IMAGING SYSTEM PASSED ALL TESTS AND IS UP AND RUNNING. THE X-STAGE COVER AND GANTRY MOTION CONTROLLER WERE RECEIVED BY THE MANUFACTURER FOR EVALUATION. ANALYSIS OF THE MOTION CONTROLLER COULD NOT CONFIRM THE REPORTED PROBLEM. THE GANTRY MOTION CONTROL BOX WAS INSTALLED IN THE TEST IMAGING SYSTEM 267 AND RAN WITHOUT ANY ISSUES. ANALYSIS OF THE X-STAGE COVER CONFIRMED THE REPORTED DAMAGE, FINDING THAT IT WAS DENTED AND HAD SCRATCHED PAINT. THE PARTS WERE REPLACED AND THE ISSUE WAS RESOLVED. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(6) ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (B)(6). 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 REPORTED MALFUNCTION WAS NOT PREVIOUSLY ASSOCIATED WITH SERIOUS INJURIES. SIMILAR MALFUNCTIONS THAT HAD RESULTED IN SIGNIFICANT DELAYS OF SURGERY OR REQUIRED ADDITIONAL INTERVENTION HAD BEEN REPORTED AS MDR SERIOUS INJURIES. BASED ON THIS 483 OBSERVATION, THE REPORTING DETERMINATION HAS BEEN REVISED TO CONSIDER THESE MALFUNCTION EVENTS REPORTABLE. 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 IMAGING SYSTEM WAS AROUND THE PATIENT AND THE DOOR COULD NOT BE OPENED. THE USER COMPLETED THE RE-HOMING PROCESS WAS COMPLETED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE IMAGING SYSTEM AFTER A REPORTED DELAY OF LESS THAN ONE HOUR. THE PATIENT WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730572 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