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

Model Number	LTF-190-10-3D
Medical Device Problem Codes	Poor Quality Image (1408); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the deflectable videoscope image was compromised, and it was observed that part of the distal end may have fallen off.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information was added to the following fields: b3, b5, d8, d9, h3, h4, h6.The device was returned to olympus for inspection, and the customer's complaint of image compromise (pink image) was not confirmed, and part of the distal end may have fallen off (deterioration of glue at the distal end section) complaint was 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 of the pink image, the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Additionally, based on the results of the investigation the deterioration of glue at the distal end section, it was presumed that due to no defects were observed that could affect the subject event; therefore, we could not specify the root cause of the event.However, it may be assumed that physical stress such as bumping or dropping or chemical stress of chemical solution in use is applied to the distal end section of the endoscope, may cause the issue to occur.The user may be able to prevent the subject of deterioration of glue at the distal end section by implementing in accordance with the following items in information for use (ifu).Instructions operation manual for ltf-190-10-3d ¿important information ¿ please read before use¿ instructions reprocessing manual for ltf-190-10-3d chapter 3, ¿compatible reprocessing methods and chemical agents¿ section 3.1, ¿compatibility summary¿.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The event occurred on the (b)(6) 2024, before procedure with no patient involvement.There was no harm/injury or infection to the patient/operator.The image was pink.

• 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: 20410256
• Report Number: 9610595-2024-20525
• Device Sequence Number: 9070621
• Product Code: GCJ
• UDI-Device Identifier: 04953170434938
• UDI-Public: 04953170434938
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K123365
• 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
• Report Date (Section B): 03/06/2025

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-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2015
• 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