MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III BRONCHOVIDEOSCOPE

Model Number	BF-XP190
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a definitive root cause could not be determined.Based on the results of the investigation and previous investigations through the product technical investigation (pti) process, reasonably known information suggests probable causes such as material problems like degradation or inappropriate material, or a mechanical problem like leakage/seal, stress, deformation, or wear and tear.These causes can occur between components such as circuit board, connector/coupler, electrical cable, electrical and magnetic, mechanical/structural cable, imager, lenses, optical fiber, handpiece, tip, mesh and marker without any design or manufacturing issue that could lead to image defects.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
It was reported the bronchovideoscope had "image breakdown at downside angle" in the service log.The event occurred during inspection for use.There were no reports of patient involvement.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• 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: 22565373
• Report Number: 9610595-2025-14832
• Device Sequence Number: 13073362
• Product Code: EOQ
• UDI-Device Identifier: 04953170434990
• UDI-Public: 04953170434990
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K201758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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-XP190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2019
• 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