BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5838958 · Received August 1, 2016

    Report

    Report Number
    1723170-2016-01524
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    March 6, 2015
    Report Date
    August 1, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. NO PARTS WERE RECEIVED BY THE MANUFACTURER. EVENT PROBLEM AND EVALUATION: ON 6-MAR-2015, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE ROTOR WOULD STOP SPINNING VERY SUDDENLY DURING A SPIN. FOUND ONE OF THE RADIOLOGIC TECHNOLOGIST¿S DOSIMETER BADGES INSIDE THE GANTRY CABLE CHAIN AREA. REMOVED THE BADGE, RAN A 3D SPIN, AND IT PASSED. THE RADIOLOGY MANAGER WAS ALERTED ABOUT THE CAUSE OF THE REPORTED ISSUE. THE USER ALSO REPORTED DIFFICULTY DRIVING THE SYSTEM; HOWEVER, NO PROBLEMS WERE FOUND WHEN DRIVING IT AROUND. THE IMAGING SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. 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 (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 WHEN ATTEMPTING TO ACQUIRE A 3D SPIN DURING A SPINAL FUSION PROCEDURE, A POPPING SOUND WAS HEARD AND THE IMAGING SYSTEM SHUT OFF. WHEN THE SYSTEM WAS REMOVED FROM THE OPERATING ROOM, ANOTHER POPPING SOUND WAS HEARD WHILE IT WAS BEING DRIVEN DOWN THE HALL. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488871 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