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

Model Number	EB-580T
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
[inspection of actual device]: when the actual scope was inspected, it was able to be confirmed that the bending rubber was stretched and covered the distal end, causing the distal end to swell.[reproduction experiment]: fujifilm conducted a reproduction experiment using a combination of the eb-580t (maximum diameter of the insertion portion: 7.1 mm) and an endotracheal tube that has little room for the insertion portion.The bending rubber sticks to the inner wall of the endotracheal tube due to friction, and when the eb-580t is removing from the endotracheal tube, the bending rubber is stretched in the direction of the distal end cap, and a similar phenomenon was reproduced.[cause analysis]: from the results of actual scope inspection and reproduction experiment, the cause of occurrence was considered as follows.(1) used in combination with an endotracheal tube that has little room in diameter for the insertion portion diameter of eb-580t (the one used at the facility has an inner diameter of 7.5 mm) (2) the bending portion was caught on the inner wall of the endotracheal tube, and when trying to remove in that state, the bending rubber stretched and covered the tip.(3) the tip of eb-580t swelled compared to the inner diameter of the endotracheal tube (4) it became difficult to remove eb-580t from the endotracheal tube.[consideration for health hazard]: the endotracheal tube may be blocked due to this bending rubber malfunction (the tip becomes swollen), making it difficult for the patient to inhale, it cannot be denying the possibility.However, normally, when it becomes difficult to remove the endotracheal tube, as in the case in question, the scope is removed together with the endotracheal tube, so the possibility of serious health damage is considered low.This report is being submitted in an abundance of caution.
Event or Problem Description
On (b)(6) 2023, fujifilm corporation was received additional information of an event involving eb-580t.Prior to the additional information, fujifilm corporation determined the incident non-reportable.It was reported that during procedure using a combination of a bronchoscope eb-580t and an endotracheal tube at the facility, when the eb-580t was withdrawn through the endotracheal tube, the eb-580t was difficult to withdraw due to the bending rubber migrating to the distal end.The eb-580t was removed along with the endotracheal tube and replaced with another scope, and the procedure was continued and completed successfully.The patient has not complained of any health hazards.There is no serious injury and death occurred associated with this event.

• Brand Name: FUJIFILM BRONCHOSCOPE MODEL EB-580T
• 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: 17699327
• Report Number: 1000513161-2023-00059
• Device Sequence Number: 7521503
• Product Code: EOQ
• UDI-Device Identifier: 14547410400394
• UDI-Public: (01)14547410400394
• 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): 09/07/2023
• Report Date (Section F): 09/06/2023

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-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: 07/06/2023
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/06/2023