BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6082376 · Received November 7, 2016

    Report

    Report Number
    1723170-2016-04107
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    February 10, 2015
    Report Date
    November 5, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SITE REPRESENTATIVE REPORTED THAT DURING A DECOMPRESSION SPINE CASE THE SURGEON TOOK A 3D SPIN AND THE IMAGES WERE BLANK. THE SCOUT IMAGES WERE NORMAL AND IT SHOWED A 3D SPIN WITH 192 IMAGES BUT WHEN THEY CLICKED ON IT THERE WAS NOTHING SHOWN. THEY TRANSFERRED THE IMAGE TO THE STEALTH AND THEY COULD SEE THE PERC PIN IN THE SAGITTAL VIEW WITH STRIATIONS BUT ALL OF THE OTHER VIEWS WERE BLANK. THE SITE REPRESENTATIVE ATTEMPTED TO REBOOTED THE MOBILE VIEW STATION (MVS) BUT THIS DID NOT RESOLVE THE ISSUE. AFTER REBOOT THE RAD/GAIN FLUORO CALIBRATION WARNING CAME UP INDICATING THAT IT WAS 8 DAYS PAST DUE. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED. AN ON SITE INSPECTION WAS SCHEDULED FOR A LATER DATE. DURING THE ON SITE INSPECTION, THE LOGS WERE SENT TO THE MANUFACTURER FOR ANALYSIS AND THE SYSTEM CONTROL BOARD WAS REPLACED. A SUCCESSFUL SYSTEM CHECKOUT WAS PERFORMED WHICH VERIFIED THAT THE ISSUE HAD BEEN RESOLVED. THE SYSTEM CONTROL BOARD WAS NEVER RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE LOGS WERE ANALYZED IN A SOFTWARE INVESTIGATION WHERE A FAILURE WAS INDICATED AFTER ONE OF THE 3D SPINS WHICH COULD RESULT IN BLANK IMAGES. THE LOGS DID NOT PROVIDE SUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF THE SPECIFIC 3D SPIN FAILURE OR THE OCCURRENCE OF THE BLANK IMAGES. 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 SITE REPRESENTATIVE REPORTED THAT DURING A DECOMPRESSION SPINE CASE THE SURGEON TOOK A 3D SPIN AND THE IMAGES WERE BLANK. THE SCOUT IMAGES WERE NORMAL AND IT SHOWED A 3D SPIN WITH 192 IMAGES BUT WHEN THEY CLICKED ON IT THERE WAS NOTHING SHOWN. THEY TRANSFERRED THE IMAGE TO THE STEALTH AND THEY COULD SEE THE PERC PIN IN THE SAGITTAL VIEW WITH STRIATIONS BUT ALL OF THE OTHER VIEWS WERE BLANK. THE SITE REPRESENTATIVE ATTEMPTED TO REBOOTED THE MOBILE VIEW STATION (MVS) BUT THIS DID NOT RESOLVE THE ISSUE. AFTER REBOOT THE RAD/GAIN FLUORO CALIBRATION WARNING CAME UP INDICATING THAT IT WAS 8 DAYS PAST DUE. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED. AN ON SITE INSPECTION WAS SCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734799 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 68 YR