MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

Model Number	BF-UC180F
Medical Device Problem Codes	Break (1069); No Display/Image (1183); Detachment of Device or Device Component (2907); Environmental Particulates (2930); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ultrasonic bronchofibervideoscope was not possible to perform the leak test, as the equipment did not have rubber at the time of evaluation and inspection.The inspection found a loose distal cover, associated with possible improper handling during use of the equipment, and the image test with significant loss of vision, caused by broken fibers, a condition consistent with previous moisture ingress, which could have led to internal crystallization and subsequent degradation of the fibers.And the distal cover with dirt present, possibly due to an improper reprocessing process.The issue occurred at preparation for use and before the patient was in the room.There were no reports of patient involvement.
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
Updated: b5, d9, h2, h3, h6, h11.This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, the most probable cause of this complaint is expected or random component failure without any design or manufacturing issue.The reported problems could be caused by either excessive or inadequate physical force exerted on it by another object resulting in problems e.G.Wear, bending, deformation, fracture, fatigue.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 II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Common Device Name: ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23898133
• Report Number: 3002808148-2025-26572
• Device Sequence Number: 15981786
• Product Code: PSV
• UDI-Device Identifier: 04953170243233
• UDI-Public: 04953170243233
• Combination Product (Y/N): N
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2026

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-UC180F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown