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

Model Number	BF-H190
Medical Device Problem Codes	No Display/Image (1183); Residue After Decontamination (2325); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported no image involving an olympus bronchovideoscope.There was no patient injury reported.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was reproduced.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: 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: 50869904
• Report Number: 9610595-2026-78250
• Device Sequence Number: 15781511
• Product Code: EOQ
• UDI-Device Identifier: 04953170335174
• UDI-Public: 04953170335174
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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-H190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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