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

Model Number	BF-PE2
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was found during the evaluation that the bronchofiberscope exhibited that the forceps channel port is shaved.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 is shaved.Based on the results of the investigation, the probable causes such as damage of parts due to deterioration/ leakage/ some kind of physical stress, without any design or manufacturing issue.The most probable cause of this complaint is expected or random component failure without any design or manufacturing issue.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Should additional relevant information become available, a supplemental report will be submitted.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: 24125866
• Report Number: 9610595-2026-06564
• Device Sequence Number: 5867396
• Product Code: EOQ
• UDI-Device Identifier: 04953170339974
• UDI-Public: 04953170339974
• 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): 01/20/2026

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: Health Professional
• Device Model Number: BF-PE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2008
• 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
• Patient Sex: Unknown