MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III BRONCHOVIDEOSCOPE; Bronchoscope (Flexible Or Rigid)

Model Number	BF-H190
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the bronchovideoscope to the service center for a unspecified image issue.During the device analysis, the investigator indicated no image.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was identified.Based on the results of the investigation, a root cause could not be identified.Reasonably known information suggests probable causes such as material problems like; degredation; inappropriate material.Mechanical problems like: leakage/seal; stress; deformation; wear and tear.Clinical imaging problem like radiofrequency induced overheating.Thermal problems like overheating.Environmental problems like: temperature; dust or dirt; humidity.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.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Common Device Name: Bronchoscope (Flexible Or Rigid)
• 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: 50900086
• Report Number: 9610595-2026-79319
• Device Sequence Number: 6001727
• Product Code: EOQ
• UDI-Device Identifier: 04953170335174
• UDI-Public: 04953170335174
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K252341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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-H190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/17/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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