MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III VIDEO SYSTEM CENTER

Model Number	CV-190
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the video system center¿s front panel stopwatch setting could no longer be activated on panel switches 1 and 2.It was not specified during what type of device usage the reported event occurred.There was no report of patient injury or medical intervention associated with this event.
Additional Manufacturer Narrative
The olympus technical assistance center reviewed the device settings with the customer and assisted in making the necessary changes to device to resolve the reported event.The event evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additional information: h4, h6, h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the issue was related to selecting the wrong user in the user settings.Once the correct user was selected, the stopwatch function worked as expected by pressing the button or the 2 on the front panel.The cause is presumed to be a wrong selection because the issue has been resolved.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 20365150
• Report Number: 3002808148-2024-09596
• Device Sequence Number: 15173170
• Product Code: FET
• UDI-Device Identifier: 04953170305535
• UDI-Public: 04953170305535
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K131780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: CV-190
• Was Device Available for Evaluation?: No
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2021
• 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