MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ARIETTA 850

Model Number	N/A
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Event or Problem Description
On march 31, 2022, fujifilm healthcare americas corporation received a complaint regarding the arietta 850 ultrasound system.The site reported that during the therapeutic choledochoduodenostomy, the screen blacked out during the deployment of a boston scientific axios stent and a patient sustained a biliary perforation.A surgery was required to treat the perforation.The patient was stable post procedure.The event date is unknown.There was no death associated with this event.

• Brand Name: ARIETTA 850
• Common Device Name: ARIETTA 850
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi; chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 14215234
• Report Number: 1528028-2022-00017
• Device Sequence Number: 17191960
• Product Code: IYN
• UDI-Device Identifier: 04573596214046
• UDI-Public: (01)04573596214046(11)220113
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/26/2022

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: 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/31/2022
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2022
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 63 KG