MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

Model Number	BF-UC190F
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the ultrasound bronchofibervideoscope to the service center for a separate issue.During the device analysis, the olympus service repair technician indicated that there was a cut on the probe unit pink rubber.There was no patient involvement.
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided if available.The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: a stress problem identified.The most probable cause of the stress problem was due to a cause traced to component failure, which is an expected or random component failure without any design or manufacturing issue.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 EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE
• Common Device Name: 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 ; +1(508)207-7661
• MDR Report Key: 50897808
• Report Number: 3002808148-2026-33821
• Device Sequence Number: 12268618
• Product Code: PSV
• UDI-Device Identifier: 04953170399831
• UDI-Public: 04953170399831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183525
• 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): 09/25/2026

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: Other
• Device Model Number: BF-UC190F
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown