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

Model Number	EB-580S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Bronchial Hemorrhage (4456)
Type of Reportable Event	Death
Event or Problem Description
It was reported that visualization from eb-580s 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 8/27 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.
Additional Manufacturer Narrative
A supplemental mdrs will be submitted when additional information is available.

• Brand Name: FUJIFILM Bronchoscopes 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
• Manufacturer (Section G): FUJIFILM Healthcare Manufacturing Sano Office; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 50815166
• Report Number: 3042225166-2026-00004
• Device Sequence Number: 10677070
• Product Code: EOQ
• UDI-Device Identifier: 14547410400387
• UDI-Public: (01)14547410400387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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
• Device Model Number: EB-580S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Unknown