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

Model Number	CV-V1
Medical Device Problem Codes	No Display/Image (1183); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the video system center had no image, front panel flickers and buttons not responding.The issue occurred during preparation for use before an unespecified procedure.There was no delay and patient was not under anesthesia.There were no reports of patient harm.
Additional Manufacturer Narrative
The device 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 results of the legal manufacturer's final investigation.Additional information added to the following fields: h3, h6.The device was returned for evaluation and the customer's reported issues were partially confirmed.It was confirmed that the there was no image and the front panel switch failed to function, however, the flickering on the front panel was not confirmed.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 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely the reported issues occurred due to a faulty socket.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: 19962520
• Report Number: 3002808148-2024-07563
• Device Sequence Number: 12944433
• Product Code: FDF
• UDI-Device Identifier: 04953170356384
• UDI-Public: 4953170356384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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-V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• 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: 07/28/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GIF-LV1-GASTROINTESTINAL VIDEOACOPE
• Patient Sex: Unknown