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	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is still ongoing.Should additional information be made available, a supplemental report will be provided.
Event or Problem Description
The customer reported that during preparation for a therapeutic procedure, his olympus 3d visualization unit was experiencing an intermittent image.According to the initial reporter, the intended procedure was completed using the subject device without any report of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added: d4, e1, h3, h4, h6 a review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it's likely that the intermittent image occurred due to printed circuit board failure.A definitive root cause could not be determined.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: 20471779
• Report Number: 3002808148-2024-10082
• Device Sequence Number: 18031259
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 10/09/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2014
• 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