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

Model Number	CV-V1
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus representative reported (on behalf of the customer) that the video system center had no image.The issue was found during preparation for use, and the diagnostic procedure (gastroscopy) was canceled.There were no reports of patient harm.
Additional Manufacturer Narrative
E1: (b)(6) hospital.The device was returned and evaluated, and the customer¿s allegation of no image was confirmed.Device evaluation found that no image was due to a defective motherboard.The additional evaluation findings are as follows: led lamp error detect indicator was not working intermittently due to a defective receptacle, some of light-emitting diodes were not glowing on front panel hence front panel required replacement, corrosion found on the top cover and back panel, and minor dust inside the unit.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final 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 9 years since the subject device was manufactured.Based on the results of the investigation, it was determined that the reported issue of no image was due to the failure of the mother board.It was confirmed that front-panel failures caused the part front-panel led light issue.Also, the led of the lamp error detection indicator was intermittently not working due to a failure of the receptacle.However, the root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 17664552
• Report Number: 3002808148-2023-09270
• Device Sequence Number: 15202049
• Product Code: FDF
• UDI-Device Identifier: 04953170312359
• UDI-Public: 04953170312359
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111756
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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-V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2014
• 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