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

Model Number LTF-S190-10

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

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, the customer's originally reported issue of flickering image was not confirmed.The following additional findings were also noted: scratch on bending section cover, chip on the adhesive of the bending section cover, deformed video connector and longer than normal angle wire due to wear.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, since the event was not reproducible on inspection, it is presumed, that it occurred due to contamination of the electrical contacts of the system.However, a definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): [inspection of the endoscopic image].Confirm that the wli and nbi endoscopic images are normal.1.Before inspection, wipe the objective lens using clean lint-free cloths moistened with saline solution or sterilized water.2.Observe the palm of your hand in the wli and nbi endoscopic images.3.Confirm that light is output from the endoscope¿s distal end.4.Adjust the brightness level as appropriate.5.Confirm that the wli and nbi endoscopic images are free from noise, blur, fog, or other irregularities.6.Turn the angulation control levers slowly in each direction until it stops.7.Confirm that the wli and nbi endoscopic images do not momentarily disappear or display any other irregularities.Olympus will continue to monitor the field performance of this device.

Event Description

A distributor reported to olympus on behalf of the customer, that there was a flickering and sometimes a color bar displayed in the image of their endoeye flex deflectable videoscope.The procedure was completed with the same device.Therefore, there was no delay in the therapeutic procedure.There were no reports of patient or user harm associated with this event.

• 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: 16792238
• MDR Text Key: 313825485
• Report Number: 9610595-2023-06531
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/21/2023

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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