MAUDE Adverse Event Report: FUJIFILM Corporation EB-580S; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 08/27/2026, fujifilm healthcare americas corporation became aware of an event involving eb-580s.It was reported that visualization was lost during a procedure.The procedure treatment was delayed to bleeding in a lung.It took ten minutes to find a different room and to get different scope.Per customer, the patient died a few hours after the incident on (b)(6) 2026 due to bleeding in the lung.The visualization was lost on reentry of the scope.Patient was intubated prior to start of procedure.The procedure was not completed after replacing the scope.The bleeding being treated was not the result of the device.Fujifilm healthcare americas corporation is reporting this event, however the cause of death due to existing condition.Ref: fujifilm healthcare americas corporation complaint # (b)(4).

• Brand Name: EB-580S
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): FUJIFILM Corporation; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 50782620
• Report Number: 1000513161-2026-00026
• Device Sequence Number: 10530039
• Product Code: EOQ
• UDI-Device Identifier: 14547410400387
• UDI-Public: (01)14547410400387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/18/2026
• 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
• Date Report Sent to FDA: 09/16/2026