MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM GASTROSCOPE MODEL EG-740UT; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	EG-740UT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference complaint #: (b)(4).
Event or Problem Description
On april 18th, 2025, fujifilm healthcare americas corporation was informed of an event involving eg-740ut.The eg 740ut endoscope shows no visible damage or functional issues during the initial inspection.However, it has been flagged for further evaluation due to a suspected infection in a patient after its use.As a safety precaution, the scope has been quarantined.The suspected scope has undergone atp testing with additional hld (high-level disinfection) cleaning.Importer mdr is being submitted in an abundance of caution since the investigation is still ongoing at the customer site and have not provided their result.

• Brand Name: FUJIFILM GASTROSCOPE MODEL EG-740UT
• Common Device Name: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• MDR Report Key: 22038652
• Report Number: 1000513161-2025-00016
• Device Sequence Number: 8123422
• Product Code: FDS
• UDI-Device Identifier: 14547410416173
• UDI-Public: (01)14547410416173(11)230301
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025
• Report Date (Section F): 04/29/2025

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: EG-740UT
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown