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	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000192, lot/serial #: unknown ; product id: bi71000144, lot/serial #: unknown ; product id: bi71000429, lot/serial #: unknown ; product id: bi71000273, lot/serial #: ; unknown h3) the manufacturer representative went to the site to test the imaging system.The door does not open.Inspected that the door cable slides were snapped, door winch assy was broken, rotor tractor drive was missing teeth.The winch assy was replaced, door cable slides were replaced, rotor tractor drive was replaced, and upper door cap was replaced as a result of troubleshooting.Full functions check performed on gantry door and rotor.System works as intended.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 in an unknown procedure.It was reported that the gantry door was stuck closed around a patient.The manufacturer representative (rep) called into the operating room after the door became stuck.The rep reported that the door would move and respond to pendant commands except for opening and closing the door.The site had attempted to reboot the system several times prior to the rep's arrival.Troubleshooting was performed and technical services (ts) had the rep attempt to use the yellow override button to open the door, but it was unsuccessful.Ts had the rep attempt to open the door manually with the ratchet wrench and t-pin.The rep reported seeing orange surface through the t-pin hole and turning the ratchet counter-clockwise but the orange surface never moved.There was a notable scratch mark on the orange surface that was used to confirm lack of movement.The site claims to have heard a loud clunk while the door was closed.Ts believes gantry cable may have snapped.The site continued with the procedure with the patient still in the system and to remove the patient after the procedure.Both nav igation and imaging were aborted.
Additional Manufacturer Narrative
(h2,h6) the component was returned to the manufacturer for analysis.Analysis found that confirmed reported complaint, "door stuck closed." test drive motor assembly with motion cart.Forward and backwards motion passed, brake was engaging and disengaging as normal.Visual inspection shows damaged/ missing teeth on drive belt.Damaged assembly.B01,c07,d02 are applicable (h2,h6) the component was returned to the manufacturer for analysis.Analysis found that confirmed reported complaint, "door stuck closed." door winch assy was broken per fse.Test winch motor assembly with motion cart.Forward and backwards motion passed, brake was engaging and disengaging as normal.Drive assembly functioned as normal.Visual inspection shows the threaded portion of the winch cable was damaged/ missing the threads.Damaged cable.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: bi71000192, serial/lot #: (b)(6), rev.K; product id: bi71000429, serial/lot #: (b)(6), rev.K 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.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: 23336787
• Report Number: 3004785967-2025-00664
• Device Sequence Number: 20822604
• Product Code: OWB
• UDI-Device Identifier: 00763000616564
• UDI-Public: (01)00763000616564(11)220719
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/10/2025

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: 09/24/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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.; SEE H11.
• Patient Sex: Unknown