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

Model Number LTF-S190-5

Device Problems Image Display Error/Artifact (1304); Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the allegation was confirmed.Additional issues were identified during the device evaluation: there was a blooming in the image, the bending section adhesive part was missing, the operating part angle fixing part was loose, and scratches were found on the bending section, video connector, operation grip, angle lever, right/left lever, up/down plate, nigiri cover, light guide connector, light guide cover glass, and the video connector case.Device history records: the device history records for this device were reviewed, and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Complaint history review: there was no complaint of the same or similar event as the reported event at the same facility and on the same device.However, a similar complaint, (b)(4), was initiated by another facility for the same device.Conclusion: the root cause could not be identified.However, it was presumed that the failure of the internal circuit board inside the control section or inside the video connector or the system was caused by stress from repeated use, external factors, or handling.The instruction manual operation manual per "chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system" describes the following warning: confirm that the wli and nbi endoscopic images are normal.Before inspection, wipe the objective lens using clean, lint-free cloths moistened with saline solution or sterilized water.Observe the palm of your hand in the wli and nbi endoscopic images.Confirm that light is output from the endoscope¿s distal end.Adjust the brightness level as appropriate.Confirm that the wli and nbi endoscopic images are free from noise, blur, fog, or other irregularities.Turn the angulation control levers slowly in each direction until it stops.Confirm that the wli and nbi endoscopic images do not momentarily disappear or display any other irregularities.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus that during the preparation of a therapeutic procedure, the endoeye flex deflectable videoscope displayed a bad image.The intended procedure was completed successfully.There were no reports of patient harm associated with the event.During the evaluation of the device, it was noted that the color tone of the image was abnormal due to damage to the video connector and the charge-coupled device.The image displayed was only magenta/green.This report is to capture the reportable malfunction of the abnormal color tone image noted at estimation.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: 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: 17171609
• MDR Text Key: 317589671
• Report Number: 9610595-2023-09103
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310355
• UDI-Public: 04953170310355
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2023

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
• Device Operator: Health Professional
• Device Model Number: LTF-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1