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

Model Number LTF-S190-5

Device Problems Corroded (1131); Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Event Description

The customer reported the image of the endoeye flex deflectable videoscope was bad.The issue was found when preparing the scope for use in a therapeutic procedure.There was no delay and the procedure was completed.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the complaint was confirmed and the image had noise and temporarily could not be seen due to damage on the charged coupled device (ccd) unit and corrosion on the electrical contact of the video plug section.The report is being submitted due to damaged ccd unit and corroded electrical contacts found during evaluation.

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings, evaluation found the bending section cover was chipped, the angulation lever did not move smoothly due to damage on the control section, the bending section could not be firmly fixed due to damage on the forceps elevator lever, the light guide connector was deformed, and multiple parts of the scope were scratched.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide results of the investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.The device was last repaired in august 2022.Although it was determined that the defects were likely caused by damage of the image sensor unit or breakage of the mounting components of the electric board due to stress, external factors, or handling, a definitive root cause of there being no image due to corrosion of the electrical contacts and failure of the charged coupled device (ccd) unit could not be identified.If additional information becomes available at a later date, this report will be supplemented.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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16581133
• MDR Text Key: 311696306
• Report Number: 9610595-2023-04737
• 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
• Report Date: 04/14/2023

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: 02/26/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2018
• 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