BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6071021 · Received November 1, 2016

    Report

    Report Number
    1723170-2016-03474
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    June 9, 2014
    Report Date
    November 1, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS REPORTER WAS UNAWARE IF PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. DURING THE IMAGING SYSTEM CHECKOUT, THE MECHANICAL TEST FAILED. THE ROTOR CANNOT FIND HOME. THE MEDTRONIC REPRESENTATIVE FOUND ROTOR HOMING TAB DAMAGED AND ROTOR HOME OPTICAL SWITCH BROKEN. HE REPLACED ROTOR HOME REFERENCE AND THE OPTICAL SWITCH. THEN HOMED ROTOR WITH NEW OFFSET VALUE. PERFORMED GAIN CALIBRATIONS. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE DEVICE PARTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION OF THE OPTICAL SWITCH CONFIRMED REPORTED PROBLEM "BROKEN OPTICAL SWITCH" AND THE INVESTIGATION OF ROTOR HOMING TAB CONFIRMED REPORTED PROBLEM "ROTOR HOMING TAB DAMAGED." THE HARDWARE INVESTIGATION FOUND THE REPORTED EVENT WAS RELATED TO MECHANICAL FAILURE OF BOTH OF THE RETURNED PARTS, FAILURE MECHANISM WAS MALFUNCTION, WEAR. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA (B)(4) OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: (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 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 BIOMED REPRESENTATIVE REPORTED THAT SUCTION TUBING GOT STUCK WITHIN GANTRY OF THE IMAGING SYSTEM. THEY ATTEMPTED TO OPEN/ CLOSE THE IMAGING SYSTEM, BUT THE SYSTEM UNABLE TO FULLY CLOSE AND NOT FUNCTIONAL. REPORTER WAS UNAWARE IF THIS ISSUE OCCURRED DURING SURGERY, BUT IT WAS REPORTED THAT NO PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721950 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