MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM BRONCHOSCOPE MODEL EB-530T; VIDEO BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	EB-530T
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Airway Obstruction (1699); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ref comp (b)(4).
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving eb-530t.It was reported that the lens is broken.In addition, airway endo tracheal tube became clogged with blood.Endotracheal tube changed with a 7.5 size.Provider forced scope in a tube that was too small.

• Brand Name: FUJIFILM BRONCHOSCOPE MODEL EB-530T
• Common Device Name: VIDEO BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• MDR Report Key: 18431995
• Report Number: 1000513161-2023-00085
• Device Sequence Number: 6751829
• Product Code: EOQ
• UDI-Device Identifier: 14547410330158
• UDI-Public: (01)14547410330158(11)171001
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2024

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-530T
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2023
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2024
• 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: Required Intervention
• Patient Sex: Unknown