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

Model Number	OTV-SI
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus the video system was flickering intermittently during reprocessing.The customer confirmed that the patient was not under anesthesia, therefore, there was no patient involvement nor any medical intervention as a result of the reported event.
Additional Manufacturer Narrative
The device will not be returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h6.Corrected fields: d10, e1.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO SYSTEM
• 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: 18924132
• Report Number: 3002808148-2024-02521
• Device Sequence Number: 17745026
• Product Code: FET
• UDI-Device Identifier: 04953170169892
• UDI-Public: 04953170169892
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K954451
• 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): 04/03/2024

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: OTV-SI
• 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: 03/03/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2012
• 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: ENF-VT
• Patient Sex: Unknown