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

Model Number	BF-P180
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was no image on the subject device.This occurred during maintenance.There were no reports of patient involvement.
Additional Manufacturer Narrative
Based on the results of the investigation and previous investigations through the product technical investigation (pti) process, reasonably known information suggests probable causes for the image issues include: 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.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction is being made to previously submitted g3 - date received by manufacturer.The correct date was 3/5/2025.
Event or Problem Description
No additional information received from customer.
Event or Problem Description
There is no new information provided by the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information and results of the final investigation.Please see updates to d8, d9, h2, h3, h6, and h11.The device was returned to olympus for inspection, and the reportable malfunction was confirmed due to damage on the charged coupled device (ccd) unit.An additional reportable malfunction was found during evaluation where the adhesive on the bending section cover was detached.Based on the results of the investigation, the reported event was most likely due to damage or deterioration of parts, environment problem such as dust/dirt/humidity, optical problem, overheating problem, and electrical problems like as signal loss or open circuit.The most probable cause of this complaint is expected or random component failure without any design or manufacturing issue.The root cause could not be specified.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 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: 21724077
• Report Number: 9610595-2025-04906
• Device Sequence Number: 11760623
• Product Code: EOQ
• UDI-Device Identifier: 04953170308192
• UDI-Public: 04953170308192
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 06/12/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 03/31/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2009
• 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