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

Model Number	BF-P190
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified procedure the subject device did not present an image.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
Correction to previous d4 - primary udi number the correct primary udi number is (b)(4).
Additional Manufacturer Narrative
Updated: b5, h2, h11.This report is being supplemented to provide additional information based on the approved final investigation.The customers¿ allegation was confirmed.Based on the results of the investigation, the root cause of the reported event could not be identified/determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No new information has been provided by the customer.

• 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 ; 5082077661
• MDR Report Key: 20952151
• Report Number: 9610595-2024-40578
• Device Sequence Number: 7584584
• Product Code: EOQ
• UDI-Device Identifier: 04953170317965
• UDI-Public: 04953170317965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201758
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/29/2025

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-P190
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 04/23/2025; 08/04/2025; 11/25/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 05/19/2025; 08/04/2025; 11/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2012
• 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
• Patient Sex: Unknown