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

Model Number	BF-P180
Medical Device Problem Codes	No Display/Image (1183); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the bronchovideoscope exhibited no image.The issue occurred during service/maintenance (not in a clinical setting).There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction, additional information and results of the final investigation.Please see correction to d5, updates to d8, h2, h3, h4, h6, and h11.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the results of the investigation, the most probable cause of the reportable event is due to some kind of stress such as damage or deterioration of parts, electrical problem, environmental temperature problem, and maintenance problem.The most probable cause of this complaint is expected or random component failure without any design or manufacturing issue.The root cause was not specified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
There is no new information provided by the customer.
Additional Manufacturer Narrative
Correction: the initial date of awareness (g3) has been corrected to 07apr2025.Additional information h11: in addition, the following reportable malfunctions were identified during the device evaluation: insertion tube had coating peeling 1 millimeter (mm) or more due to deterioration.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from 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: 21975736
• Report Number: 9610595-2025-07936
• Device Sequence Number: 9197357
• Product Code: EOQ
• UDI-Device Identifier: 04953170308192
• UDI-Public: 04953170308192
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

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-P180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 07/28/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/25/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2010
• 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