MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number	BI70000028120
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an imaging system during an unknown procedure.It was reported that the gantry would not open.They manually opened the gantry.Delay in surgery and patient impact were not provided.Additional information was received.It was reported that images were not taken.
Additional Manufacturer Narrative
(h3, h6): manufacturing representative went to the site to test the system, customer complaint not verified.Gantry was able to complete 360 spins, door opened and closed with no issues.Verified alignment with the t- handle.Grab logs for date of occurrence.Performed system checkout, device return to service.H3, h6: a software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi-500-00186, serial/lot#: (b)(6).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 1000 IMAGING SYSTEM 3RD EDITION
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22344040
• Report Number: 3004785967-2025-00389
• Device Sequence Number: 8520023
• Product Code: OXO
• UDI-Device Identifier: 00643169353428
• UDI-Public: 00643169353428
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K092564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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: BI70000028120
• Device Catalogue Number: BI70000028120
• 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: 06/11/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2015
• 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