BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 5977735 · Received September 26, 2016

    Report

    Report Number
    1723170-2016-03452
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    January 21, 2015
    Report Date
    September 26, 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. EVENT PROBLEM AND EVALUATION: ON 21-JAN-2015, A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM. SEVERAL PIECES OF DRAPE MATERIAL WERE FOUND INSIDE THE GANTRY. THE ROTOR FUNCTIONED WITHOUT ISSUE AFTER THE DRAPE MATERIAL WAS REMOVED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE SITE WAS ADVISED TO VISIBLY WATCH THE DOOR CLOSE DURING CASES TO ENSURE DRAPES STAYED OUT OF THE DOOR WHILE CLOSING. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. 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 MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A SPINAL FUSION PROCEDURE, THE ROTOR OF THE IMAGING SYSTEM BECAME UNRESPONSIVE WHEN ATTEMPTING TO MOVE IT FROM AP TO LATERAL POSITION. A ¿DOOR OPEN¿ MESSAGE DISPLAYED ON THE PENDANT, AND THE SYSTEM WAS UNRESPONSIVE TO THE YELLOW EMERGENCY BUTTON. DURING TROUBLES-SHOOTING, THE SITE WAS ABLE TO MANUALLY OPEN THE DOOR FROM AROUND THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE IMAGING SYSTEM. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629104 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