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

Model Number	LTF-S190-10
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was confirmed.A root cause could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that while using the subject device, the video image did not appear and there was a blackout.The reported malfunction occurred during setup prior to an unspecified therapeutic procedure.There were no reports of patient harm.
Event or Problem Description
It was reported that while using the subject device, the video image did not appear and there was a blackout.The reported malfunction occurred during setup prior to an unspecified therapeutic procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to h11.The information provided in h11 was inadvertently omitted from the 1st supplemental report.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the results of the investigation, the event occurred due to a defective video connector of the product, however, a definitive root cause could not be established.It is likely the following led to the malfunction: external electrical stress (application of static electricity by directly contacting the electrical contacts, short circuits due to connecting the electrical contacts while they were wet, etc.) was repeatedly applied to printed circuit board inside the video connector, which led to deterioration of electronic parts.As a result, the operation became unstable.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that while using the subject device, the video image did not appear and there was a blackout.The reported malfunction occurred during setup prior to an unspecified therapeutic procedure.There were no reports of patient harm.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Common Device Name: FLEX 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20859862
• Report Number: 9610595-2024-40388
• Device Sequence Number: 4032250
• Product Code: GCJ
• UDI-Device Identifier: 04953170434662
• UDI-Public: 04953170434662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2025

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 02/03/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/15/2025; 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2019
• 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