MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 3D VISUALIZATION UNIT

Model Number	3DV-190
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for inspection, and the reported failure was confirmed via information from technical assistance support (tac).A definitive root cause could not be identified.Based on the results of the investigation, it is likely that the reported malfunction "not outputting 2d correctly" was due to incorrectly configured settings.The customer contacted olympus technical assistance support (tac) via phone.The customer was asked to check the settings on the video processor and the 3-dimensional visualization unit.Then the customer was asked to update the settings which were incorrect.Settings were updated and the issue was resolved.The customer informed technical assistance support (tac) of the event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the 3d visualization unit had not output 2d images correctly.The issue occurred during inspection for use.There were no reports of patient involvement.

• Brand Name: 3D VISUALIZATION UNIT
• Common Device Name: 3D VISUALIZATION UNIT
• 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: 24198985
• Report Number: 3002808148-2026-02524
• Device Sequence Number: 20204603
• Product Code: FET
• UDI-Device Identifier: 04953170338229
• UDI-Public: 04953170338229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: 3DV-190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2017
• 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