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

Model Number EB-530T

Device Problems Break (1069); Fracture (1260)

Patient Problems Airway Obstruction (1699); Hemorrhage/Bleeding (1888)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

Ref comp (b)(4).

Event 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
• Type of Device: 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
• MDR Text Key: 331860547
• Report Number: 1000513161-2023-00085
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 14547410330158
• UDI-Public: (01)14547410330158(11)171001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention