MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ULTRASONIC ENDOSCOPE EB-530US; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	EB-530US
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving eb-530us.It was reported that during a treatment procedure the b20bu balloon detached from the bronchoscope and was found in the patient's airway, requiring immediate intervention to remove the balloon.The balloon was retrieved without patient harm and the procedure was completed successfully.There is no serious injury or death associated with the event.

• Brand Name: FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
• 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
• MDR Report Key: 17234780
• Report Number: 1000513161-2023-00035
• Device Sequence Number: 7536234
• Product Code: EOQ
• UDI-Device Identifier: 14547410330189
• UDI-Public: 0114547410330189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/29/2023

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-530US
• 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: 06/01/2023
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown