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	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3,h6: a medtronic representative went to the site to test the equipment.Testing revealed that found pendant had some wear on the b uttons and were slow to react to depressing.Could not replicate buttons activating a different switch than pressed.Could not replicate grey screen on related work order.Grey screen could be related to user error, zeroing the contrast scale brings image into foc us.After pendant replacement, updated firmware and performed motion calibration.Checked all button activations.Annual planned maintenance (pm) performed at this time.System is functioning correctly and was released back to service.B01,c07,d02 codes are applicable.H3,h6: the pendant was returned to the manufacturer for analysis.Analysis found that unable to confirm reported complaint.Installed pendant into test imaging system.System and pendant booted as expected.Pendant keys are still functional, but several are worn and need excessive pressure to be applied to function.Visual inspection shows the pendant laminate is starting to lifting/ bubbling up from around the keys.Worn pendant.B01, c07, d02 codes are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi 71000529rpend, serial/lot #: (b)(6) rev.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.
Event or Problem Description
Medtronic received information regarding an imaging system being used for cervical spine procedure.It was reported that during a case, when attempting to press left on the pendant, the system performed a tilt.This issue occurred intraoperatively and did not cause any surgical delay.There was no reported impact on patient outcome.

• 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: 22666868
• Report Number: 3004785967-2025-00527
• Device Sequence Number: 14409269
• Product Code: OWB
• UDI-Device Identifier: 00763000355555
• UDI-Public: (01)00763000355555(11)210424
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 98 KG