MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE II VIDEO SYSTEM CENTER

Model Number	OTV-S300
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation before use the subject device displayed abnormal noise on the screen, and it was unable to work normally.There were no reports of patient harm.
Additional Manufacturer Narrative
E1 facility name: (b)(6) hospital.E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional the investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
The issue occurred during preparation for use before patient room, the procedure was completed.There were no reports patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation, the legal manufacturer's final investigation updated fields: a2, a3, a4, a5, a6, b5, b6, b7, d8, d10, h2, h3, h4, h6 (health effect code, type of investigation, investigation findings and investigation conclusions) and h11.The device was returned to olympus for inspection and the reported failure was not confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: device was unable to work normally and the internal cable had poor contact.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA ELITE II VIDEO SYSTEM CENTER
• Common Device Name: VIDEO SYSTEM 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21026271
• Report Number: 3002808148-2024-39285
• Device Sequence Number: 8342991
• Product Code: FET
• UDI-Device Identifier: 04953170386060
• UDI-Public: 04953170386060
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K202646
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: OTV-S300
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown