MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION OASIS XP 1.2T OPEN MRI SYSTEM; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number N/A

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  malfunction  

Event Description

On june 17,2022 fujifilm healthcare corporation received a complaint regarding oasis xp 1.2t open mri system.The customer complained about the quality of breast imaging.The patient is a known breast cancer patient and is actively undergoing treatment.The site reported the discrepancy in the size of a lesion that was 75 mm on a non-fujifilm system (scan was done on (b)(6) 2022) vs only 5 mm on the oasis xp 1.2t open mri system (scan was done on (b)(6) 2022).There is no death or serious injury associated with event.

Manufacturer Narrative

Fujifilm is investigating the root cause and a supplemental report will be submitted pending investigation results.

Manufacturer Narrative

On 07/22/2022, fujifilm healthcare corporation concluded its root cause investigation.There were no device-related issues identified as a result of the investigation.It was concluded that it is likely that the issue was due to user error.The training records were reviewed and determined to be adequate, and retraining was determined to be unnecessary.

• Brand Name: OASIS XP 1.2T OPEN MRI SYSTEM
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: katsuyuki minagawa ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-804 ; JA 277-0804
• MDR Report Key: 14880386
• MDR Text Key: 303258950
• Report Number: 3018423337-2022-00008
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)190508(250)G210035619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female