MAUDE Adverse Event Report: FUJIFILM CORPORATION OASIS MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	SYS/MR/OASIS OPEN+VERTEX II
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 05/29/2026, fujifilm healthcare americas corporation became aware of an event involving sys/mr/oasis open+vertex ii.The customer reported that a patient complained of pain in their left hands when moved into the gantry.The patient #1 did not seek any further medical attention but did not complete the study that they were originally scheduled.Fuji engineer has completed the transmitter testing and temperature testing.Due to the unconfirmed follow up to complete the originally scheduled study, fujifilm healthcare americas corporation is reporting this event in an abundance of caution.Related: patient 2 - 1000513161-2026-00013.Ref: fujifilm healthcare americas corporation complaint # (b)(4).

• Brand Name: OASIS MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 25640975
• Report Number: 1000513161-2026-00012
• Device Sequence Number: 9837046
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)180619(250)G210059218
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2026
• Report Date (Section F): 06/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SYS/MR/OASIS OPEN+VERTEX II
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/29/2026
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/26/2026