MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BI70002000
Medical Device Problem Codes	Positioning Problem (3009); Radiation Output Failure (4027); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6) the manufacture representative went to the site to test the imaging system and ias (imaging acquisition system) would not boot up.No power was being produced out of standalone board.Replaced standalone board and then found that there was no 15.Vdc on load side of power supply.Replaced power supply.System went back to nominal state.Performed system checkout.All systems performing to operating standards.Supply board was not used.Would sent back.Mdr codes: b01, c02, d02.H3, h6) the component was returned to the manufacturer for analysis.Analysis found confirmed reported complaint, "unable to perform spin." visual inspections showed multiple components were electrically over stressed.Mdr codes: b01, c02, d02.Returned date: 2025-11-18 h3, h6) the component was returned to the manufacturer for analysis.Analysis found confirmed reported complaint, "unable to perform spin." visual inspections showed components r20 and r21 were electrically over stressed.Mdr codes: b01, c02, d02.Returned date: 2025-11-18 continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000225, serial/lot #: (b)(6); product id: bi71000577; product id: bi71000450, 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.
Event or Problem Description
Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that the site stated, during a case this morning after taking scout images, they went to take a 3d spin and the gantry stopped and the ias went to the initializing screen and would not perform the spin.They removed system from room, and continued case with the other o-arm.This occurred intraoperatively, and there unknown delay.There was no reported impact on patient involved.Additional information received "there was 10 mins of surgical delay".

• 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 45640 ; MX 45640
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (BOXBOROUGH); 200 beaver brook rd; boxborough,ma 45640 ; MX 45640
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23828891
• Report Number: 3004785967-2025-00809
• Device Sequence Number: 9267887
• Product Code: OWB
• UDI-Device Identifier: 00763000132378
• UDI-Public: (01)00763000132378(11)200824
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K200074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: BI70002000
• Device Catalogue Number: BI70002000
• Device Lot Number: -
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• 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