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

Model Number LTF-S190-10

Device Problems Signal Artifact/Noise (1036); Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

An olympus representative reported that the endoeye flex deflectable videoscope had a flickering image.During inspection and evaluation, the color tone of the image is abnormal due to damage to the imaging unit.(image is magenta or green only).There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during incoming inspection and evaluation.

Manufacturer Narrative

The device was returned to olympus for inspection, and the customer's allegation was confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: due to damage on charged coupled device (ccd) unit, a noise image occurs, due to damage on lock engagement lever, bending section cannot be fixed firmly, due to damage on ccd unit, the image has white dots, and chips and scratches found throughout the device.The investigation is on-going.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, the root cause of the event was unable to be identified.It is likely the image sensor unit has been damaged (disconnection, etc.), or the mounted parts (ic chip, capacitor, etc.) of the electric board have failed due to use stress, external factors, or handling.The inspection method for the event is described as follows in the instructions for use (ifu) "chapter 3 preparation and inspection 3.8 checking the function in combination with related equipment"."[inspection of endoscopic images] check if normal light observation images and nbi observation images are displayed normally.1.Wipe the endoscope tip lens with sterile gauze moistened with saline or sterile water before inspection.2.Observe the palm, etc.With normal light observation images and nbi observation images.3.Make sure the light is coming out.(see figure 3.23) 4.Adjust the amount of light to get the proper brightness.5.Check that there are no abnormalities such as noise, blur, or cloudiness in the normal light observation image and the nbi observation image.6.Operate the angle lever of the endoscope to bend the curved part.7.Check that normal light observation images and nbi observation images do not disappear for a moment or other abnormalities." olympus will continue to monitor field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17076586
• MDR Text Key: 316867669
• Report Number: 9610595-2023-08504
• 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,Followup
• Report Date: 07/10/2023

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: 05/14/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• 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