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

Model Number	OTV-S7PRO
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the video system center displayed no image when switched on.The issue occurred during preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the reportable malfunction was confirmed due to solid green and pink image (subject not visible) on the monitor screen.Based on the results of the investigation, the pink and green image was likely caused by a defective circuit board; however, a definitive root cause could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA PRO 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20467745
• Report Number: 3002808148-2024-10060
• Device Sequence Number: 17949043
• Product Code: FET
• UDI-Device Identifier: 04953170228896
• UDI-Public: 04953170228896
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K062049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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-S7PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2014
• 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