MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Model Number	LTF-190-10-3D
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the deflectable videoscope displayed no image.The issue occurred during preparation for use for an unspecified procedure.The unspecified procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.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 since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) section below: ifu ltf-190-10-3d operation manual chapter 3 preparation and inspection:3.6 inspection of the endoscopic system: inspection of the endoscopic image.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
• Common Device Name: FLEX 3D DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20268637
• Report Number: 9610595-2024-18886
• Device Sequence Number: 11604333
• Product Code: GCJ
• UDI-Device Identifier: 04953170434938
• UDI-Public: 04953170434938
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: LTF-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2016
• 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