MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER

Model Number	EU-ME1
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while under sedation for a diagnostic endobronchial ultrasound-guided transbronchial needle aspiration, the ultrasound image quality was poor.The issue occurred mid-procedure causing a surgical prolongation greater than 30 minutes.The issue was resolved after utilization of a new scope and balloon.There were no reports of patient harm.
Event or Problem Description
This supplemental report is being submitted to provide additional information from the customer and the results of the legal manufacturer¿s investigation.Updated fields: b5, h2 and h6.Corrections to b1, b2, and h1.This event was initially conservatively reported as a serious injury; however, upon further follow-up, the customer confirmed that the patient did not suffer any serious injury or adverse effects from the prolonged procedure, thus correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported and other findings would not cause or contribute to a death or a serious injury if it were to recur.The device was not returned to olympus for inspection and the reported failure was not confirmed.A definitive root cause could not be identified due to no findings available.Olympus will continue to monitor field performance for this device.

• Brand Name: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
• Common Device Name: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• MDR Report Key: 21211846
• Report Number: 2429304-2025-00041
• Device Sequence Number: 11719281
• Product Code: IYN
• UDI-Device Identifier: 04953170355639
• UDI-Public: 04953170355639
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025
• Report Date (Section F): 04/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EU-ME1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/14/2025
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON; SCOPE
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/08/2025