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

Model Number	3DV-190
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Technical assistance center (tac) support engineer performed troubleshooting with the customer (company representative (rep)), found that the cv behavior ( visualization unit system) currently set to standalone.Tac instructed the rep to change cv behavior from standalone to master.Once completed, rep.Was able to manually toggle between 2d/3d and can also use scope switch to toggle.Issue was resolved by changed of cv behavior from standalone to master setting.Investigation however is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported, a 3d scope connected to 3dv-190 tower, cannot toggle between 2d and 3d (two-dimentional/three dimentional motion images).By using the button on the front of the 3dv-190 (subject device).There was no patient involvement on this reported event.No harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on customer response to follow up.Communication with the customer company representative , the following information conveyed: the event occurred on april 24, 2023.The issue with the device was discovered during initial set up.No further information was provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Section g2 was corrected to include information that aligns with the initial report.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, and because the issue was resolved through troubleshooting, the definitive root cause of the front panel switch issue which led to the toggle failure could not be determined.It is possible that the settings of the device caused the issue.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿the two video system centers (cv-190) need to be set to ¿master¿ and ¿slave¿ respectively.Enter the setting values as described in section 4.2, ¿basic operation of the system setup¿, in the instruction manual for the video system center (cv-190).¿ 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: 16905755
• Report Number: 3002808148-2023-04720
• Device Sequence Number: 14817505
• Product Code: FET
• UDI-Device Identifier: 04953170338229
• UDI-Public: 04953170338229
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 05/18/2023; 06/19/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 05/24/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3D SCOPE.
• Patient Sex: Unknown