MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BI70002000
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an imaging system being used for a pending surgical procedure.It was reported that the manual door open procedure failed as the gantry would not open while positioned around the patient.The site attempted to use the emergency door button, but it did not work.They then tried the manual door open procedure.Although the indicator turned orange, the t-handle would not seat properly.When they managed to seat it correctly and began ratcheting the handle, they felt immediate resistance and chose not to proceed.The imaging system was moved toward the base of the patient bed, and the surgery continued.The length of the surgical delay was pending.The patient outcome was pending.Additional information was received.The procedure being performed was a sacroiliac and thoracolumbar procedure and there was a surgical delay as the site was never able to get the imaging system open so they had to improvise to get the patient off the table and dismantled the surgical bed to get the imaging system out.Surgical delay amount unknown.The screws that were placed were unable to be checked and the issue occurred intra-operatively.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000273, serial/lot #: -, ubd: , udi#: h3) the manufacturer representative went to the site to test the imaging system.Adjusting the screws on the door slide stop mechanism was loose.They adjusted and tightened.System operates as expected 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): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer (Section G): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22373378
• Report Number: 3006544299-2025-00591
• Device Sequence Number: 7953025
• Product Code: OWB
• UDI-Device Identifier: 00763000068097
• UDI-Public: (01)00763000068097(11)180829
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2018
• 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 Sex: Unknown