MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	EB-580S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer wants three bronchoscopes evaluation to be performed due to patient(s) infection event.The customer confirmed there were three patients involved and positive candida was confirmed.
Additional Manufacturer Narrative
An inspection of three bronchoscopes revealed malfunctions such as a distal end cap chipped, crushed/bite mark at the bending sections, etc.Endoscopes with damage to the distal end, insertion section, or other parts may not be properly cleaned and disinfected during the reprocessing procedure, potentially leaving contamination that could serve as a source of infection.However, the cause of this event has not yet been identified.Fujifilm will conduct further investigations and submit a supplemental report if additional information is available.

• Brand Name: FUJIFILM BRONCHOSCOPE
• 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: 24777000
• Report Number: 3001722928-2026-00007
• Device Sequence Number: 6134255
• Product Code: EOQ
• UDI-Device Identifier: 14547410400387
• UDI-Public: (01)14547410400387
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K183607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/03/2026

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: 03/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Unknown