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

Model Number	OTV-SI
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: b5, d5, h2, h3, h6, h11 the device was returned to the regional service center for inspection and the reported failure was not confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: cause not established olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the subject device had a lamp error.There were no reports of patient harm.

• 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 ; 5082077661
• MDR Report Key: 20772083
• Report Number: 3002808148-2024-37980
• Device Sequence Number: 15475944
• Product Code: FET
• UDI-Device Identifier: 04953170169885
• UDI-Public: 04953170169885
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: Other
• Device Model Number: OTV-SI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2015
• 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
• Patient Sex: Unknown