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	Mechanical Problem (1384); Failure to Advance (2524); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
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 the gantry door would not open when it was around the patient.Loud thumping noise by the door when pressing open button.Yellow button did not work.Manually cranking door open was successful.This issue occurred intraoperatively and caused less than one hour surgical delay.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
H3, h6): the manufacturing representative (rep) went to site to test the imaging system and found that the stand alone board is the part that loose magnets on metal cable chain track.Fse replaced missing magnets on cable chain with trunkstock parts.Fse cleaned interior of gantry.Fse also inspected rotor rollers that spin on nylon track and found two rollers that are not freely spinning which are the cause of the noise during spin.So, replaced the rollers on the rotor gantry.After replacing parts, the gantry ceased to make thumping sound.System functioning as designed.Codes b01, c07, d02 are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000105; product id: bi71000105; product id: bi71000105; product id: bi71000105.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: 24130210
• Report Number: 3004785967-2026-00039
• Device Sequence Number: 10400169
• Product Code: OWB
• UDI-Device Identifier: 00763000068097
• UDI-Public: (01)00763000068097(11)180817
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2018
• 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 Age: 57 YR
• Patient Sex: Female