MAUDE Adverse Event Report: FUJIFILM CORPORATION ED-580XT DUODENOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	ED-580XT
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
Event or Problem Description
On april 18th, 2025, fujifilm healthcare americas corporation was informed of an event involving eg-740ut.The ed-580xt 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.
Additional Manufacturer Narrative
Reference complaint #: (b)(4).

• Brand Name: ED-580XT DUODENOSCOPE
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• MDR Report Key: 22038836
• Report Number: 1000513161-2025-00017
• Device Sequence Number: 8436879
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• 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: ED-580XT
• 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