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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3,h6) no parts have been received by the manufacturer for evaluation.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi 71000442rpend; product id: bi71000444rpend; product id: bi71000192: 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 outside of the procedure.It was reported that the gantry door was getting stuck when opening/closing.There was no patient involved.
Additional Manufacturer Narrative
H3, h6) the manufacture representative went to the site to test the imaging system and customer reported system was having issues when opening gantry door.Found the rotor tractor drive to be the cause of the issue.Replaced part correcting the problem.Verified door was opening/closing properly.System checkout completed in accordance with the as per user manual.System was fully functional and had been returned to the customer.Mdr codes: b01, c07, d02.H3, h6) the component was returned to the manufacturer for analysis.Analysis found that confirmed reported complaint, "gantry opening issue." test motor assembly with motion cart.Forward and backwards motion passed, brake was engaging and disengaging as normal.Visual inspection showed belt was missing teeth and causes the belt to skip, not allowing gantry to spin correctly.Damaged assembly.Mdr codes: b01, c07, d02.Return date: 2025-07-10 h3, h6) the component was returned to the manufacturer for analysis.Analysis found that unable to confirmed reported complaint, "gantry opening issue." installed control box into test system.The system booted and readied on each power cycle.Performed motion calibrations, all passed.Door functioned as normal and motion travel on all axes was smooth and functional.Performed 2d and 3d images, all were successful.No fault found while under test.Mdr codes: b01, c19, d14.Return date: 2025-07-09 continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id:bi71000442rpend , serial/lot #: (b)(6), product id: bi71000192 , 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 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: 22343234
• Report Number: 3006544299-2025-00546
• Device Sequence Number: 20058808
• Product Code: OWB
• UDI-Device Identifier: 00763000863302
• UDI-Public: (01)00763000863302(11)240628(21)C3874
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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