MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS 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	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(h3,h6): manufacturing representative went to the site to test the system, field service engineer(fse) found the door failed to close all the way when fse attempted to fully close it.Fse found door slides had been sheared off due to excessive force of cables on slides.They require replacement.Replace door winch cable and replace door slides.System functioning as designed.H2-3) the part was returned to the manufacturer for evaluation.After functional testing and visual/physical examination, the reported issue was unable to confirm reported complaint.Test winch motor assembly with motion cart.Forward and backwards motion passed, brake was engaging and disengaging as normal.Winch assembly functioned as normal.Visual inspection shows normal wear.No functional fault found.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#: ; product id: bi71000429, serial/lot #: (b)(6).Rev.8, ubd: , udi#: ; product id: bi71000166, serial/lot #: -, ubd: , udi#: ; product id: bi71000556, serial/lot #: -, ubd: , udi #: 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 sacroiliac and thoracolumbar procedure.It was reported that the door got stuck about a quarter of the way when attempting to open the gantry from around a patient.It would not close or open after it got stuck.The site rebooted the system, but that didn't resolve the issue.The site resorted to opening the gantry manually to remove it from around the patient.They had another imaging system that they used to continue the case.There was a delay of about 10 minutes.There was no impact on patient outcome.

• 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: 22343952
• Report Number: 3006544299-2025-00548
• Device Sequence Number: 4901511
• Product Code: OWB
• UDI-Device Identifier: 00763000068066
• UDI-Public: 00763000068066
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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: 06/11/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2018
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 82 KG