MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM EB-530 SERIES BRONCHOSCOPE EB-530H; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	EB-530H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The distal end portion of the subject bronchoscope had separated from the insertion portion, exposing parts inside the insertion portion.The forceps channel tube and other parts inside the insertion portion were connected to the distal end portion and the parts of the bronchoscope did not fall off into the patient body.It is possible that the distal end portion and the insertion portion were damaged by excessive force, but the cause has not yet been identified at this time.Fujifilm will submit a supplemental report when additional investigation results are available.
Event or Problem Description
On april 18th 2024 fujifilm corporation was informed of an event involving eb-530h.It was reported that the end of the scope is ripped apart, and the wires are exposed.Durning the procedure a snare was hooked onto the scope and pulled down the patient, resulting in ending the procedure.X-ray was done to make sure no parts/ piece of the scope were left.Patient was good.
Additional Manufacturer Narrative
Fujifilm was informed from the facility that the subject bronchoscope was used with an endotracheal tube (manufacturer and model name unknown) and a treatment device (boston scientific snare, model name unknown) was attached to the outside the bronchoscope insertion portion.Although fujifilm was unable to obtain sufficient information from the facility, we considered the cause based on the limited information and the results of our investigation of the actual device.Based on the following (1) (2) (3), it is thought that the damage was further aggravated by repeated forced operations while the bronchoscope was damaged, leading to the exposure of the internal parts of the insertion section of the bronchoscope.(1) the multiple tears on the distal end portion side of the bending rubber may have been caused by contact with the snare during the procedure.(2) the fact that the bending rubber was slack and covering the distal end portion, and that an endotracheal tube was being used, means that the part where the multiple tears occurred on the bending rubber distal end portion side was likely to have caught on the inside of the endotracheal tube due to friction, and that the bending rubber was slackened as a result of the bronchoscope being forcibly pulled out of the endotracheal tube.(3) continuing from (2), it is thought that the distal end portion of the subject bronchoscope had separated from the insertion portion, exposing parts inside the insertion portion due to the attempt to forcibly pull it out further.

• Brand Name: FUJIFILM EB-530 SERIES BRONCHOSCOPE EB-530H
• 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
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING SANO OFFICE; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 19328421
• Report Number: 3001722928-2024-00018
• Device Sequence Number: 3101803
• Product Code: EOQ
• UDI-Device Identifier: 04547410330168
• UDI-Public: (01)04547410330168
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K122535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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-530H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown