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

Model Number	BF-P190
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the bronchovideoscope to the service center for a separate issue.During the device analysis, the investigator indicated the objective lens is missing glue, and the light guide lens is chipped.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.Adhesive issue: reasonably known information suggests probable causes such as material problems like: degredation.Mechanical problems like: device migration; stress; wear and tear; leakage; lubrication.These causes can occur between components such as mesh; tube; cover; label; cannula; coating material; power cord; electrical cable; tip; adhesive; lenses; electrode; housing; stain relief; handpiece; access port; camera; and connector/coupler; knob; ring; prong; tube; joint; switch/relay; connector pin; plate; and lenses without any design or manufacturing issue.That could lead to apperance issues.Lens issue: reasonably known information suggests probable causes such as material problems like: degredation.Mechanical problems like: device migration; stress; wear and tear; leakage; lubrication.These causes can occur between components such as mesh; tube; cover; label; cannula; coating material; power cord; electrical cable; tip; adhesive; lenses; electrode; housing; stain relief; handpiece; access port; camera; and connector/coupler; knob; ring; prong; tube; joint; switch/relay; connector pin; plate; and lenses without any design or manufacturing issue.That could lead to apperance issues.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: 50899660
• Report Number: 9610595-2026-79300
• Device Sequence Number: 5829107
• Product Code: EOQ
• UDI-Device Identifier: 04953170342110
• UDI-Public: 04953170342110
• Combination Product (Y/N): N
• 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: Foreign,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-P190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/09/2026
• 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: 01/10/2019
• 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