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

Model Number	OTV-S200
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the power did not turn on while preparing for use during inspection for use involving an olympus video system center.During the initial evaluation of the returned device, it was observed that the visual field was too dark or too bright and that the video signal output was abnormal.No patient involvement was reported.
Additional Manufacturer Narrative
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: VISERA ELITE II 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50870325
• Report Number: 3002808148-2026-33475
• Device Sequence Number: 18810046
• Product Code: FET
• UDI-Device Identifier: 04953170386015
• UDI-Public: 04953170386015
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K200542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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-S200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• 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