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

Model Number	3DV-190
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the 3d visualization unit experienced a no image issue.The event was found during procedure.The intended procedure (therapeutic total laparoscopic hysterectomy (tlh)) was not delayed.There was no impact, harm or injury to the user or patient associated with the event.
Additional Manufacturer Narrative
Olympus was able to troubleshoot with the customer, walking through the wiring and settings.When the link cable was mentioned, the customer checked and realized it was not plugged in properly.Once plugged in properly, the live images became available.The customer was still unable to send images however.An additional olympus resource went through cabling also, everything was correctly cabled.Additional experimenting of settings was performed.Eventually, the 3d image was visible on port a and could then save the recording and were able to get the 3dv to work as intended.No further action is required.The device will not be returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.
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.Based on the results of the investigation, the root cause could not be conclusively determined as the device was not returned for evaluation.However, based on the troubleshooting performed over the phone, the reported event occurred due to user error as the link cable was not properly connected.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: 17445761
• Report Number: 3002808148-2023-07881
• Device Sequence Number: 2494466
• Product Code: FET
• UDI-Device Identifier: 04953170338229
• UDI-Public: 04953170338229
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2013
• 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
• Patient Sex: Unknown