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	04/07/2025
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: bi71000429, serial/lot #: (b)(6) rev.K, ubd: , udi#: ; product id: bi71000273, product id: bi71000144, serial/lot #: (b)(6) rev.2, product id: bi71000135, serial/lot #: (b)(6) rev.2, the manufacturer representative (rep) went to the site to test the imaging system.The door winch was bound up due to being improperly opened manually.They replaced the door winch and broken covers.System check was good; the system was operational.Codes: b01, c07, d02 the cover was returned for analysis (bi71000144).Visual inspection showed two of the four standoffs for mounting cover to the system were damaged and cover had a large crack.There was physical damage to the cover.Codes: b01, c07, d02 returned: 2025-apr-29 the cover was returned for analysis (bi71000135).The cover failed visual inspection.The standoffs on the inside of the cover were broken off.Physically damage was observed.Codes: b01, c07, d02 returned: 2025-apr-29 the door winch was returned for analysis (bi71000429).They tested the winch motor assembly with motion cart.Forward and backwards motion passed, brake was engaging and disengaging as normal.Drive assembly functioned as normal.No failure was found.Codes: b01, c19, d14 returned: 2025-05-22 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 outside of the procedure.It was reported that the imaging system gantry would not fully open and that site had to use the emergency wrench to get it fully open.There was no patient involved.

• 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: 22414015
• Report Number: 3006544299-2025-00661
• Device Sequence Number: 15869150
• Product Code: OWB
• UDI-Device Identifier: 00763000542849
• UDI-Public: (01)00763000542849(11)220512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/07/2025

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: 05/22/2025
• 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: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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 Sex: Unknown