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

Model Number	CV-190
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During evaluation, the following were found: the color of the image was not good and the white balance could not be set due to defective, printed circuit board failure and a fail of white balance adjustment.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the evis exera iii video system center had a color bar in the image and the object was visible.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the correction of the initial mdr and the legal manufacturer's final investigation.Corrected fields: e1 (add phone number), e2 was inadvertently checked on the initial mdr (this information is unknown), and g2 (health care professional was inadvertently checked on the initial mdr, this information is not known.) additional information h6 a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over eight (8) years since the subject device was manufactured.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be a faulty printed circuit board.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: 17673909
• Report Number: 3002808148-2023-09330
• Device Sequence Number: 6434663
• Product Code: FET
• UDI-Device Identifier: 04953170305535
• UDI-Public: 04953170305535
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 08/09/2023
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2015
• 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