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

Model Number	BF-3C160
Medical Device Problem Codes	Corroded (1131); No Display/Image (1183); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A definitive root cause could not be determined.Based on the results of the investigation and previous investigations through the product technical investigation (pti) process, reasonably known information suggests probable causes such as material problems like degradation or inappropriate material or a mechanical problem like leakage/seal, stress, deformation, or wear and tear.These causes can occur between components such as circuit board, connector/coupler, electrical cable, imager, and optical fiber, without any design or manufacturing issue that could lead to image defects.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
It was observed that during the device evaluation, the broncho videoscope exhibited corrosion on the connector, connection issues with the electrical connector, and no image.There was no patient involvement.

• Brand Name: EVIS EXERA 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: 22866672
• Report Number: 9610595-2025-18462
• Device Sequence Number: 13055209
• Product Code: EOQ
• UDI-Device Identifier: 04953170340031
• UDI-Public: 04953170340031
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K023984
• 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
• Report Date (Section B): 08/21/2025

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: Other
• Device Model Number: BF-3C160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2017
• 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