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

Model Number	3DV-190
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the visualization unit when connected with the main monitor could not output a 3d image.The image appeared to be out of alignment.The issue occurred at preparation for us for a diagnostic procedure.The procedure was completed with a different set of equipment.There were no reports of patient harm.
Additional Manufacturer Narrative
E1 establishment full name:(b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than ten (10) years since the subject device was manufactured.Based on the results of the investigation, it was not possible to specify the root cause of the suggested event.However, it was confirmed that an error occurred in the outgoing images due to a failure of the printed circuit board, but it was not possible to identify the factors that led to the failure of printed circuit board.As a result of checking the instructions for use and labeling of the products, there were no abnormalities that could lead to the phenomenon.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19571094
• Report Number: 3002808148-2024-05595
• Device Sequence Number: 4057702
• Product Code: FET
• UDI-Device Identifier: 04953170338229
• UDI-Public: 04953170338229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2024

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: 3DV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2013
• 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: CV-190 (B)(6); CV-190 (B)(6); LMD-2451MT 3100941; LTF-190-10-3D
• Patient Sex: Unknown