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

Model Number	OTV-S7V
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
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 visera video system center displayed a flickering image.The issue occurred during a diagnostic urological examination procedure.The procedure was completed using the same set of equipment.There were no reports of patient harm.
Event or Problem Description
The issue occurred during preparation before use for the procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, updates to fields d8, d10, and h4, as well as corrections to fields b5, g2, and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection, and the reportable malfunction was not confirmed, however, a no image event was found.Based on the results of the investigation, and although we could not specify the root cause of the suggested event, it is likely the defect was caused by an abnormality that occurred in the image display due to a faulty video connector socket.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 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: 20135102
• Report Number: 3002808148-2024-08409
• Device Sequence Number: 20654750
• Product Code: FET
• UDI-Device Identifier: 04953170141546
• UDI-Public: 04953170141546
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051645
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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-S7V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CV-290THE EVIS LUCERA ELITE VIDEO SYSTEM CENTER; S7 CAMERA
• Patient Sex: Unknown