BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 5831803 · Received July 28, 2016

    Report

    Report Number
    1723170-2016-01782
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    December 28, 2015
    Report Date
    July 28, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OWB
    PMA / PMN Number
    K151000
    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 TESTED THE IMAGING SYSTEM AND FOUND THE UPPER DINGUS WAS NOT COMPLETELY DISENGAGING WHICH DOESN'T ALLOW DOOR TO CLOSE COMPLETELY. THE MEDTRONIC REPRESENTATIVE ADJUSTED THE DOOR TO DISENGAGE UPPER DINGUS COMPLETELY. THE MEDTRONIC REPRESENTATIVE ALSO FOUND THE SYSTEM WOULD NOT DOCK, STOPPED 3" ABOVE DOCK POSITION. THE MEDTRONIC REPRESENTATIVE RELOADED GANTRY MOTION CONTROLLER FIRMWARE TO RESOLVE THE ISSUE. THE MEDTRONIC REPRESENTATIVE THEN PERFORMED AN IMAGING SYSTEM CHECK-OUT, ALL AREAS PASSED. A SOFTWARE INVESTIGATION WAS COMPLETED AND CONFIRMED THIS ISSUE WAS CAUSED BY HARDWARE THAT NEEDED ADJUSTMENT. SOFTWARE IS FUNCTIONING AS DESIGNED. 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 MDR'S 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 PROMPTED THE USER TO CALIBRATE MOTION. THE SITE ATTEMPTED TO CALIBRATE THE SYSTEM BUT REPORTED IT WOULD NEVER COMPLETE. TO TROUBLESHOOT THE ISSUE, THE IMAGING SYSTEM WAS REBOOTED SEVERAL TIMES WITHOUT RESOLUTION. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481081 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR