BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6067739 · Received October 31, 2016

    Report

    Report Number
    1723170-2016-03258
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    July 8, 2015
    Report Date
    October 31, 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

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. MECHANICAL TEST FAILURE FOUND THAT THE IMAGING SYSTEM DOOR WINCH WAS NOT WORKING, A NEW PART WAS ORDERED. CABLE GRADE FAILURE SHOWED THAT THE CABLE WAS SPLINTERING IN SEVERAL SECTIONS AND NOT RIDING IN "TRACKS" ON ASSEMBLY. THE FOLLOWING DAY, THE MEDTRONIC REPRESENTATIVE REPLACED THE X-STAGE COVER. THE MECHANICAL TEST DID NOT YET PASS THE SYSTEM CHECKOUT, WAITING ON WINCH ASSEMBLY SHIPMENT FOR REPLACEMENT. THE MEDTRONIC REPRESENTATIVE RETURNED TO THE SITE TO TEST THE EQUIPMENT AND REPLACED DOOR WINCH ASSEMBLY, RESET DOOR OPEN/CLOSE ODOMETER. THE IMAGING SYSTEM WAS TESTED AND FOUND TO BE READY FOR USE. THE IMAGING SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. ISSUE RESOLVED WITH PART REPLACEMENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION OF THE DOOR WINCH CONFIRMED REPORTED PROBLEM "WORN ROLLERS AND CABLE." VISUAL INSPECTION FOUND DOOR WINCH KIT ASSEMBLY IS SHOWING EXCESSIVE SIGNS OF WEAR. WORN ROLLERS, WORN CABLE AND SHEARED GEARS. THE HARDWARE INVESTIGATION FOUND THAT REPORTED EVENT WAS RELATED TO A MECHANICAL FAILURE MODE, FAILURE MECHANISM REPORTED TO BE MALFUNCTION, WEAR. 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 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 (B)(4) 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 HE RECEIVED REPORT THAT AFTER A SUCCESSFUL 3D SPIN THE IMAGING DOOR WOULD NOT OPEN. SPIN STILL TRANSFERRED SUCCESSFULLY AND SURGEON WAS ABLE TO NAVIGATE DURING THE SPINAL FUSION PROCEDURE. DURING TROUBLESHOOTING, CLOSED DOOR, REBOOTED THE IMAGING SYSTEM AND TRIED OPENING AGAIN, SAME ISSUE. MEDTRONIC REPRESENTATIVE INSTRUCTED THE RADIOLOGIC TECHNOLOGIST (RT) TO MANUALLY OPEN THE DOOR BUT THIS WAS NOT SUCCESSFUL. THERE WAS WITH NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE AND NO KNOWN IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718766 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 70 YR