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

Model Number	BF-MP190F
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported " damaged".The issue was found during reprocessing.There was no patient involvement in this reported event.Device inspection found image noise.
Additional Manufacturer Narrative
The subject device was received and evaluated.Device evaluation noted the reported customer issue was confirmed.Evaluation noted the device had multiple parts which were damaged.Evaluation found dents in the electrical connector, dents in the connector coupler.The plug unit was defective.The ccd had shrunk tube and with cut.Additionally, as noted in section b5, the device was found with image noise.Based on investigation results, the reported customer issue was confirmed.Probable cause based on reasonably known information based on device evaluation was due to physical stress, wear, deformation, fracture, fatigue, component failure.Based on investigation results, the image issue was noted to be due to damage component failure and attributed to electronic component failure.Olympus will continue to monitor complaints for this device.

• Brand Name: EVIS EXERA III BRONCHOFIBERVIDEOSCOPE
• Common Device Name: BRONCHOFIBERVIDEOSCOPE
• 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: 23993386
• Report Number: 9610595-2026-02042
• Device Sequence Number: 10531170
• Product Code: EOQ
• UDI-Device Identifier: 04953170395581
• UDI-Public: 04953170395581
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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-MP190F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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