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

Model Number	ED-580XT
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Scar Tissue (2060); Laceration(s) of Esophagus (2398)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ref comp # (b)(4).
Event or Problem Description
On december 20th, 2024, the fujifilm americas healthcare corporation received a complaint regarding scarring of the esophagus occurred with two patients, when inserting / removing the scope.The elevator is not giving full range of motion (stuck).During the initial investigation fujifilm engineer found the elevator dose have some tension when engaging the lever, it's very mild but can see where the customer may have a concern when using the scopes elevator function.Engineer suggests removing some tension of the elevator lever, so the knob won't seem as tight per their request.The scope functions within the tolerances range and masseurs at 65 degrees (elevator).No additional information was provided from the customer.

• Brand Name: FUJIFILM DUODENOSCOPE MODEL ED-580XT
• 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: 21125665
• Report Number: 1000513161-2025-00001
• Device Sequence Number: 7676940
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 01/10/2024
• Report Date (Section F): 01/06/2025

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: Other
• Device Model Number: ED-580XT
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2024
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2025
• 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: Other
• Patient Sex: Unknown