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

Model Number	H866031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref (b)(4).During the investigation, fujifilm engineer has completed incident report and coil investigation report to resolved the issue.
Event or Problem Description
On december 6th 2023, fujifilm healthcare americas corporation was informed of an event involving sys/mr/oasis open+vertex ii.It was reported that the customer requested a review on an abdominal case.It was later reported that a dr.States that a known abdominal lesion was apparently missed on an exam completed on the velocity.There was no harm or injury to the patient.No additional information provided.
Additional Manufacturer Narrative
Ref comp (b)(4).The device is judged to be within system criteria and operating normality as a result of snr measurements.(specification: 97.8-147.2 result: 121.3).After confirmation of images on report (m302 clinical science image review) by a qualified member of the fhc' s radiological technologist, it is concluded that the liver lesions in question are also visualized by the 1.2 t oasis, although there are differences in the visibility of the different models.Fhc agrees with the result of hcus investigation which shows that this issue is due to the variances in the appearance of anatomical structures caused by the difference of mr system and scan parameters.It is recommended to use the same mr system and the same field strength when tracking a specific lesion in the same specimen.

• Brand Name: OASIS MRI SYSTEM
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 27708 04; JA 2770804
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: yasuo okamoto ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-804 ; JA 277-0804
• MDR Report Key: 18503142
• Report Number: 3018423337-2024-00001
• Device Sequence Number: 8146624
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)190801(250)G210069419
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K202030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: H866031
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 75 KG