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

Model Number	EB-580T
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2024, fujifilm healthcare americas corporation was informed of an event involving eb-580t.It was reported that there is a concern for potential defect inside the scope that could be a source for harboring bacteria.Three patients test positive with a rare bacterium and are trying to identify a source.

• Brand Name: EB-580T BRONCHOSCOPE
• 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: 18861833
• Report Number: 1000513161-2024-00018
• Device Sequence Number: 8239825
• Product Code: EOQ
• UDI-Device Identifier: 14547410400394
• UDI-Public: (01)14547410400394
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/07/2024
• Report Date (Section F): 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EB-580T
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown