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	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that system was unable to open while around a patient.Representative rebooted the system three times - issue unresolved and performed manual opening process - issue unresolved.Also reported that another imaging system was used while the initial imaging system was still around the patient.Representative reports that the gantry would go up and down but when performing manual open process, gears looked misaligned and there was resistance.This issue occurred intra operatively and caused less than 1 hour surgical delay and navigation and imaging were aborted.There was no reported impact to the patient outcome.
Additional Manufacturer Narrative
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), product id: bi71000429, serial/lot#: (b)(6), product id: bi71000273, product id: bi71000442, h3) the manufacturer representative (rep) went to the site to test the imaging system.They found that the gantry door winch assemble was broken due to over torque trying to open the doors manually.They found that the rotor tractor drive belt with multiple broken teeth.Two door slide guides were broken.The rep removed the broken screw stubs from the gantry frame.They installed the new type of door slide guides, rotor tractor drive assembly and winch assembly.They adjusted the dingus, gantry door mechanism and invalidated the home position.The tractor drive assembly was returned for analysis.They tested the tractor drive assembly with motion cart.Forward and backwards motion passed, brake was engaging and disengaging as normal.Visual inspection showed the belt had damage and missing teeth.Returned: 2024-12-19 the winch was returned for analysis.Visual inspection shows the drive gear and the cog gear had damaged teeth and the center cog gear shaft bent.Damaged door winch assembly.Returned: 2024-12-19 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: 22374755
• Report Number: 3006544299-2025-00603
• Device Sequence Number: 14562294
• Product Code: OWB
• UDI-Device Identifier: 00763000542849
• UDI-Public: (01)00763000542849(11)220425
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• 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: 04/25/2022
• 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."
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 118 KG