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

Model Number	3DV-190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, that no light-emitting diode (led) was highlighted on the panel of the 3d visualization unit.The issue was found during preparation for a therapeutic laparoscopic donor nephrectomy.The procedure was completed with a non-olympus device and no procedural delay.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found that the front panel light-emitting diode (led) was not glowing due to a faulty printed circuit board, and tracks of flat cable were found corroded.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for evaluation and the customer's allegation was confirmed.Based on the results of the investigation, the light emitting diode (led) on the front panel did not light up due to a failure of the printed circuit (cp) board.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: 18534926
• Report Number: 3002808148-2024-00543
• Device Sequence Number: 18085861
• Product Code: FET
• UDI-Device Identifier: 04953170338229
• UDI-Public: 04953170338229
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: 01/04/2024
• 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: 12/26/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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