BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM O2 IMAGING SYSTEM

    MDR report key: 23756546 · Received December 9, 2025

    Report

    Report Number
    3004785967-2025-00780
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 16, 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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3) THE SOFTWARE INVESTIGATION FOUND THAT THERE WAS NO SOFTWARE ISSUE. SOFTWARE WAS FUNCTIONING AS DESIGNED. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: M021083C001, VERSION:4.2.1 , 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.

    Additional Manufacturer Narrative · 0

    H3, H6) THE MANUFACTURE REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM AND ARRIVED ON SITE AND RECREATED ISSUE. DURING IN-DEPTH INVESTIGATION THEY FOUND SEDIMENT THAT WAS ON THE V-GROOVE ROLLER RIAL. THEY ALSO FOUND THAT THE DINGUS WAS MISALIGNED CAUSING A LOUD GRIDING NOISE. THE DINGUS WAS ONLY SLIGHTLY MISALIGNED WHICH CAUSED THIS NOISE AND FURTHER INVESTIGATION REVELED A CHIP/MARK ON THE ROTOR SPACER WHICH INDICATED THE SYSTEM STRUCK SOMETHING ON IT WAY DOWN TO CLOSE THE DOORS. THIS CHIP/MARK DID NOT INTERFERE WITH THE SYSTEMS OPERATIONS; HOWEVER, IT WAS ENOUGH OF AN IMPACT TO MISALIGN THE NOMINAL GAP BETWEEN DINGUS THE ROTOR SPACER. THEY ADJUSTED THE DINGUS PER MEDTRONIC DOCUMENTATION, CLEANED THE RAILS AND PERFORMED ALL NECESSARY CALIBRATIONS AS WELL AS A FULL SYSTEM CHECKOUT. SYSTEM WAS FULLY FUNCTIONAL AND RETURNED TO THE CUSTOMER FOR CLINICAL WORKFLOW. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: M021083C001, PRODUCT ID: BI71000105, (QUANTITY: (B)(4). 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS MAKING A GRINDING NOISE AND HAVING DIFFICULTY OPENING AFTER BEING RAN INTO A TABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008163 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."