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

Model Number LTF-S190-10

Device Problem Image Display Error/Artifact (1304)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the endoeye flex deflectable videoscope had green noise occur multiple times when the camera was connected or when a load was applied to the connection between the universal and the connector.The issue was found during inspection for use before a therapeutic procedure, which was completed with similar device without delay.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: damage on charged coupled device unit in the endoscope connector causing green color tone of the image.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.In addition to the reportable malfunction, the device evaluation found: the adhesive on bending section cover had a chip; due to wear of angle wire, the bending angle in up direction did not meet the standard value; due to damage on the forceps elevator lever, bending section could not be fixed firmly; due to damage on the charged coupled device unit, a noisy image occurs; the control unit, the grip, the angulation lever, switch 1, the video connector, the video connector case, the bending section cover, and the light guide connector had a scratch.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 2 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause cannot be identified.The event may have occurred due to a failure of the internal board of the control section, internal board of the video connector, or the system side due to external factors or handling.This issue is addressed in the instructions for use (ifu): the inspection method for the event is described as follows in "chapter 3 preparation and inspection 3.8 inspection of combination functions with related equipment".[inspection of endoscopic images] check whether normal light observation images and nbi observation images are displayed normally.1.Before inspection, wipe the lens at the tip of the endoscope with sterile gauze moistened with saline or sterile water.2.Observe the palm of the hand etc.With normal light observation image and nbi observation image.3.Make sure the lighting light is out.4.Adjust the amount of light to the appropriate brightness.5.Check that there are no abnormalities such as noise, blurring, and cloudiness in the normal light observation image and nbi observation image.6.Operate the angle lever of the endoscope to bend the curved part.7.Confirm that no abnormalities such as normal light observation images and nbi observation images disappear for a moment do not occur.Olympus will continue to monitor the field performance of this device.

• 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: 17222406
• MDR Text Key: 318339666
• Report Number: 9610595-2023-09464
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310386
• UDI-Public: 04953170310386
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111425
• 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: 06/28/2023

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• 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
• Treatment: OTV SYSTEM