BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 22840928 · Received August 19, 2025

    Report

    Report Number
    3004785967-2025-00562
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 19, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K200074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3, H6): MANUFACTURING REPRESENTATIVE WENT TO THE SITE TO TEST THE SYSTEM. THE CUSTOMER WAS UNABLE TO CLOSE THE DOOR ON THE IMAGING SYSTEM. UPON INSPECTION OF THE UNIT, IT WAS DISCOVERED THAT THEY HAD MANUALLY OPENED THE DOOR AND ATTEMPTED TO CLOSE IT MANUALLY BUT FAILED. ONCE THE COVERS WERE REMOVED AND THE DOOR WINCH ASSEMBLY WAS INSPECTED, IT WAS DISCOVERED THAT THE DOOR CABLE HAD COME OFF ITS CABLE GUIDE AND BECOME ENTANGLED WITH ITSELF, REQUIRING REPLACEMENT OF THE DOOR WINCH ASSEMBLY. A NEW DOOR WINCH ASSEMBLY WAS ORDERED AND INSTALLED, RESOLVING THE ISSUE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: BI71000429; PRODUCT ID: BI71000442. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO GET THE IMAGING SYSTEM DOOR TO OPEN WHILE IT WAS POSITIONED AROUND THE PATIENT. THE TEAM HAD TO PERFORM THE MANUAL DOOR RELEASE PROCEDURE TO REMOVE THE UNIT FROM THE OPERATING ROOM. THIS WAS OCCURRED INTRA OPERATIVELY. THERE WAS A REPORTED DELAY OF LESS THAN 1 HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394461 O-ARM O2 IMAGING SYSTEM INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) BI70002000 - 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11