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

Model Number	BF-XT190
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the bronchovideoscope when turned on in any direction lines were on the monitor during setup.No patient harm was reported.
Additional Manufacturer Narrative
The device was returned for inspection.The root cause could not be identified.Based on the results of the investigation, the customer allegation was confirmed.Additionally, the investigation observed image flickering.It is likely the following led to the malfunction: electrical/electronic problem resulting in component failure.Should additional relevant information become available, a supplemental report will be submitted.

• 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 ; +1(508)207-7661
• MDR Report Key: 50535634
• Report Number: 9610595-2026-71376
• Device Sequence Number: 13228059
• Product Code: EOQ
• UDI-Device Identifier: 04953170402470
• UDI-Public: 04953170402470
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K250862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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-XT190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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