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
Additional Manufacturer Narrative
Fujifilm healthcare corporation is performing additional investigation to determine the root cause.A supplemental report will be submitted pending results of the investigation.
Event or Problem Description
On (b)(6) 2022, fujifilm healthcare 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 is no death associated with this event.
Additional Manufacturer Narrative
On september 9, 2022, fujifilm healthcare corporation concluded the root cause investigation on the arietta 850.The error logs from the device were analyzed.It could not be confirmed that there was a causal relationship between the screen blacking out and the perforation.The available information was not enough to establish a root cause for the perforation.Fujifilm will continue to monitor all arietta 850 systems for similar issues.

• 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
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: kan tsushima ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0-804 ; JA 277-0804
• MDR Report Key: 14254848
• Report Number: 3018423337-2022-00003
• Device Sequence Number: 17351926
• 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
• PMA/510(K) Number: K183456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 63 KG