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

Model Number	EB-580S
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 03/02/2026, fujifilm healthcare americas corportation became aware of an event involving eb-580s.The customer reported a patient infection event.The patient infection organism was not identified.The customer is unable to confirm if the patient required additional medical treatment to treat the infection.Due to the patient infection, fujifilm healthcare americas corportation is reporting this event in an abdunance of caution.Ref: fujifilm healthcare americas corportation complaint #(b)(4).
Event or Problem Description
The customer confirmed positive candida results from patient specimen for this patient.There was no additional treatment was required.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 miyandai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 24692429
• Report Number: 1000513161-2026-00006
• Device Sequence Number: 10004351
• Product Code: EOQ
• UDI-Device Identifier: 14547410400387
• UDI-Public: (01)14547410400387
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026
• Report Date (Section F): 03/25/2026

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
• Device Model Number: EB-580S
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/02/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/11/2026
• 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: 03/25/2026