MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT

Model Number EG-580UT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Biliary Cirrhosis (1736); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 03/15/2021

Event Type  Death  

Event Description

On (b)(6) 2022, fujifilm corporation became aware of adverse events related to eg-580ut from an mdr submitted to fda by olympus.The report referenced scientific literature which described 5 procedure-related adverse events, of which 4 resulted in death.The adverse events involved either the fujifilm eg-580ut or the olympus gf-uct180 specific details of the procedure and the device used are not available, and the exact date of the event is unknown.The relationship between eg-580ut and the aes cannot be found in the report or related literature nor is it confirmed.As such, this case is being reported in an abundance of caution.Since no patient identifiers were provided, one report is being submitted for all five patients.

Manufacturer Narrative

This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.

• Brand Name: FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT
• Type of Device: ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: safety officer ; 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 13720759
• MDR Text Key: 286932110
• Report Number: 3001722928-2022-00003
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K221952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

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
• Device Model Number: EG-580UT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other