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

Model Number	BF-1T180
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during a therapeutic bronchoscopy performed under sedation, the distal tip of the bronchovideoscope detached and fell inside the patient¿s lung, although the treating physician attempted retrieval by aspirating the fragment with an additional bronchoscopy, the piece could not be located and is still suspected to remain inside the patient¿s lung.The procedure was completed with the same device.No additional health consequences were reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields- d8, d9, h2, h3, h6, h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus, during service evaluation, the device was determined to be obsolete.Consequently, no visual inspection or functional testing was performed.Photographic evidence of the device confirmed the reported complaint, identifying breakage and detachment of the distal cover and associated adhesive based on the results of investigation, the root cause of the reported issue could not be determined, however, the most probable cause is cause traced to component failure, expected or random component failure without any design or manufacturing issue due to degradation problem identified.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
No additional information received from the customer.

• Brand Name: EVIS EXERA II 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: 24123454
• Report Number: 9610595-2026-06530
• Device Sequence Number: 15875577
• Product Code: EOQ
• UDI-Device Identifier: 04953170339325
• UDI-Public: 04953170339325
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BF-1T180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2008
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown