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

Model Number	BF-TE2
Medical Device Problem Codes	Device Reprocessing Problem (1091); Corroded (1131); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device was returned to olympus america inc.And underwent physical inspection by qualified personnel.Based on the findings of the completed investigation, probable causes were assessed, including damage or deterioration of components, electrical issues, environmental temperature factors, and maintenance-related concerns.The most probable cause of the reported complaint is expected or random component failure, with no design deficiency or manufacturing non-conformance identified as a contributing factor to the reported event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
During the device evaluation, it was found that the returned bronchofiberscope exhibited forceps channel port sticky and shaved, and the control unit displayed corrosion due to water leakage.No patients were involved in association with this event.

• 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: 24616634
• Report Number: 9610595-2026-21735
• Device Sequence Number: 13171702
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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-TE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2018
• 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