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

Model Number	EU-ME2
Medical Device Problem Codes	No Display/Image (1183); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to h6.Code corrected to "67".
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus.The reported device defects were not confirmed.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 8 years, since the subject device was manufactured.Based on the results of the investigation, the reported device defects were not confirmed.Therefore, the root cause could not be determined.This supplemental report includes an update to h3, from the initial medwatch.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the during a diagnostic ebus-tbna (endobronchial ultrasound guided transbronchial needle aspiration) procedure, processor malfunction occurred, where the image froze and error message us1605 occurred for cell board malfunction.As such, the procedure was cut short.The sample obtained was not enough and patient may need to be rescheduled.Several lymph noted that needed to be sampled only one was sampled before the malfunction.The procedure was not able to be completed as planned.The patient needs to be rescheduled for repeat procedure.Additional follow-up has been requested but unavailable the time of the report.There were no reports of patient harm.

• Brand Name: EVIS EUS 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
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19667400
• Report Number: 3002808148-2024-06058
• Device Sequence Number: 12399429
• Product Code: IYN
• UDI-Device Identifier: 04953170343490
• UDI-Public: 04953170343490
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EU-ME2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 08/02/2024; 08/05/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/05/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown