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

Model Number	BI70002000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
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: b i71000194.H3: a medtronic representative went to the site to test the equipment and the handswitch was replaced.The handswitch was discarded by the site.The imaging system then passed the system checkout and was found to be fully functional.H6: b01, c07 and d02 apply to the system checkout.B17, c20, d15 apply to the handswitch concomitant product.This regulatory report is being submitted due to a retrospective review through capa 624392.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 spinal procedure.It was reported that it was not possible to start a 3d scan.2d was working without problems.A system restart did not solve this issue.It was noted that the probable cause of the issue was a defective hand switch button.There was a reported delay to the procedure of less than one hour.There was no reported impact to the patient.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21241513
• Report Number: 3004785967-2025-00063
• Device Sequence Number: 8605520
• Product Code: OWB
• UDI-Device Identifier: 00643169618121
• UDI-Public: 00643169618121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2015
• 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