MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (Boxborough) O-Arm O2 Imaging System; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BI70002000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an imaging system being used in an unknown procedure.It was reported that there was a navigation inaccuracy in connection with the imaging system.Patient presence was unknown.
Additional Manufacturer Narrative
H3) the manufacturer representative went to the site to test the imaging system.The site wanted a system checkout.The camera temporarily recognized the reference frame or navlock tracker orange.The navigation system had displayed the message localizer faulty.Furthermore, a navigation inaccuracy was reported in connection with imaging system.Function check carried out, camera, camera cable and connectors checked for contact problems.No error was found.Checked navigation accuracy in conjunction with the imaging system.The imaging system tracker calibration verified and passed on both sides.Navigation system in conjunction with the imaging system was ready for operation.Ndi event log checked.Warning message: "firmware incompatibility detected".After restart system info message: "firmware compatibility restored".Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi-500-01145, serial/lot #: 4.2.0, ubd: , udi#:.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.

• Brand Name: O-Arm O2 Imaging System
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (Boxborough); 200 beaver brook rd; boxborough MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (Boxborough); 200 beaver brook rd; boxborough MA 01460
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50928083
• Report Number: 3004785967-2026-00521
• Device Sequence Number: 18825147
• Product Code: OWB
• UDI-Device Identifier: 00643169618121
• UDI-Public: (01)00643169618121(11)161129
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Patient Sex: Unknown