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

Model Number	OTV-SC
Medical Device Problem Codes	No Display/Image (1183); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the camera was not working.The issue occurred during inspection for use involving a video system center.Additionally, during the initial evaluation of the returned device and the onsite inspection observed that there was no image on the monitor.No patient harm was reported.
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided once available.The investigation is still ongoing.A supplemental report will be submitted when the investigation has been completed or when new and significant information becomes available.Olympus will continue to monitor the field performance of 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50949608
• Report Number: 3002808148-2026-34374
• Device Sequence Number: 9499723
• Product Code: FET
• UDI-Device Identifier: 04953170136917
• UDI-Public: 04953170136917
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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-SC
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown