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

Model Number	EB-580T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 02/24/2026, fujifilm healthcare americas corporation became aware of an event involving eb-580t.It was reported that the tip of the bronchoscope came off and fell into the patient's airway.Customer was unable to use the scope.Customer had to retrieve the distal tip out of the airway of the patient then switch scopes.The patient has recovered and was discharged home.No additional treatment or monitoring was required.The patient did not experience any harm, injury, or complications after the procedure.The procedure was completed after switching the scope.There was a 10-minute delay to remove the piece of the scope that fell off and switch the scopes.The patient remained under anesthesia during the delay.The delay did not impact the patient or procedure.Due to a piece of the device falling into the patient's cavity, fujifilm healthcare americas corporation is reporting this event in an abdunance of caution.Ref: fujifilm healthcare americas corporation complaint #(b)(4).

• 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: 24651042
• Report Number: 1000513161-2026-00003
• Device Sequence Number: 10208083
• Product Code: EOQ
• UDI-Device Identifier: 14547410400394
• UDI-Public: (01)14547410400394
• 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): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/20/2026
• Report Date (Section F): 03/20/2026

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
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2026
• 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: 03/20/2026