MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BRONCHOFIBERSCOPE

Model Number	BF-TE2
Medical Device Problem Codes	Dent in Material (2526); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the evaluation, the bronchofiberscope exhibited that the forceps channel port has a dent.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.In addition, the investigation found that the forceps channel port has a dent.Based on the investigation, the most probable causes are possibly due to some kind of stress such as damage or deterioration of parts, electrical problems, environmental temperature problems, and maintenance problems.The most probable cause of this complaint is expected or random component failure without any design or manufacturing issue.Olympus will continue to monitor field performance for this device.

• Brand Name: BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24688000
• Report Number: 9610595-2026-24084
• Device Sequence Number: 9652987
• Product Code: EOQ
• UDI-Device Identifier: 04953170339998
• UDI-Public: 04953170339998
• Combination Product (Y/N): N
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: Other
• Device Model Number: BF-TE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown