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

Model Number LTF-S190-5

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to olympus for preliminary evaluation and inspection, and the customer's reported problem and abnormal green and magenta imagery have been confirmed.In addition, damage was found on the insertion section's charge coupled device, which caused image roughness and improper color tone during testing.The a-rubber, and a-rubber adhesive also had damage.Switch 1, the control unit, plates, grip, and lock engagement lever on the control section were found to have damage.The universal cord was also found to be dented and dirty.The light guide connector and cover glass were also found to be damaged.The video plug section's connector and main body were also found to be damaged.This investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The end user facility contacted olympus to report a repair request for abnormal imagery from a endoeye flex deflectable videoscope.The reported phenomenon occurred during inspection prior to use.During preliminary evaluation and inspection of the returned subject device, abnormal green and magenta image color tones were found.This mdr is being submitted due to the abnormal imagery found during evaluation and inspection.No patient or user harm has been reported.

Manufacturer Narrative

Including udi in d4.

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, a specific root cause could not be identified.However, it is probable that the abnormal imaging was caused by the failure of the image sensor unit, or the failure of the internal circuit board of video connector or the system caused the event.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: 15983129
• MDR Text Key: 308107919
• Report Number: 9610595-2022-05478
• 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,Followup,Followup
• Report Date: 01/30/2023

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: 11/16/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 12/14/2022; 01/05/2023
• Supplement Dates FDA Received: 12/15/2022; 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2011
• 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: VISERA ELITE SYSTEM.