BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6097184 · Received November 11, 2016

    Report

    Report Number
    1723170-2016-04626
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    March 23, 2015
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SITE REPRESENTATIVE REPORTED THAT THE 3D IMAGE RESULTED IN HALF OF THE SLICING BEING WHITE. ANOTHER 3D SCAN WAS PERFORMED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT REPORTED AND NO DELAY IN SURGERY. SURGERY PROCEEDED AS PLANNED. THE SYSTEM'S LOGS WERE SENT TO THE MANUFACTURER FOR ANALYSIS. A SOFTWARE INVESTIGATION WAS CONDUCTED TO ANALYZE THE SYSTEM LOGS WHERE IT WAS DETERMINED THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. 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: 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 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 SITE REPRESENTATIVE REPORTED THAT THE 3D IMAGE RESULTED IN HALF OF THE SLICING BEING WHITE. ANOTHER 3D SCAN WAS PERFORMED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT REPORTED AND NO DELAY IN SURGERY. SURGERY PROCEEDED AS PLANNED. THE SYSTEM'S LOGS WERE SENT TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746135 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