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

Model Number	CV-190
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was not confirmed and all functions were working correctly.The device evaluation did not find an error or damage.The device was tested with several types of scopes and camera head and the measured values did met the inspection limits.The device was set to factory settings.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the evis exera iii video system center could not detect signal and no image was produced on the monitor.The system was being restarted and the image was restored temporarily but could disappear and this happened several times.Finally, a similar device was used to complete the procedure.Reportedly, all procedures were completed as planned.There were no reports of patient harm associated with the event.Related patient identifier: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified, nor could the phenomenon be confirmed/reproduced.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: 17135925
• Report Number: 3002808148-2023-06008
• Device Sequence Number: 5773668
• Product Code: FET
• UDI-Device Identifier: 04953170305535
• UDI-Public: 04953170305535
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2013
• 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