MAUDE Adverse Event Report: FUJIFILM Corporation ALOKA ARIETTA 850

Model Number	ALOKA ARIETTA 850
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During rfa treatment, as the tip of the needle on the puncture probe was brought close to the liver mass, the device froze and became inoperable, making it impossible to confirm the position of the puncture needle.The physician therefore forcibly shut down and restarted the device, then continued and completed the procedure.There were no health effects on the patients.
Additional Manufacturer Narrative
Once the results of the investigation are available, we will submit an additional report detailing the cause and necessary actions.

• Brand Name: ALOKA ARIETTA 850
• Common Device Name: Aloka Arietta 850
• Manufacturer (Section D): FUJIFILM Corporation; 3-1-1 higashikoigakubo; kokubunji city, tokyo 185-0 014; JA 185-0014
• Manufacturer (Section G): FUJIFILM Corporation; 3-1-1 higashikoigakubo; kokubunji city, tokyo 185-0 014; JA 185-0014
• Manufacturer Contact: 3-1-1 higashikoigakubo; kokubunji city, tokyo 185-0-014
• MDR Report Key: 50814246
• Report Number: 3019784575-2026-00004
• Device Sequence Number: 21364181
• Product Code: IYO
• UDI-Device Identifier: 04573596214046
• UDI-Public: (01)04573596214046(11)251201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: ALOKA ARIETTA 850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown