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

Model Number LTF-S190-5

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

The customer reported to olympus the endoeye flex deflectable videoscope, image noise.The issue occurred during preparation for us, prior to a therapeutic operation.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found the following: due to damage on charging coupled device (ccd) unit, image noise occurs and temporary the image cannot be seen; due to damage on insertion pipe, insulation resistance value does not meet the standard value; adhesive on bending section cover or distal sheath has a scratch; adhesive on bending section cover or distal sheath has a chip; due to damage on orceps elevator lever (surgical product - sp), bending section cannot be fixed firmly; due to looseness of insertion pipe, connection between insertion pipe and control unit is not secured; a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

Updated: h6, h10.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 definitive root cause of the reported image noise issue could not be determined, however, it is likely that the issue was due to dust, dirt, foreign matter, etc.Adhering to the video connector electrical contacts and the connection was insufficient, resulting in poor electrical connection with the system and the image sensor unit malfunctioning.The event can be detected/prevented by following the instructions for use which state: 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¿.¿ wipe the endoscope tip lens with sterile gauze moistened with saline or sterile water before inspection.Observe the palm, etc.With normal light observation images and nbi observation images.Make sure the light is coming out.Adjust the amount of light to get the proper brightness.Check that there are no abnormalities such as noise, blur, or cloudiness in the normal light observation image and the nbi observation image.Operate the angle lever of the endoscope to bend the curved part.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: 17476361
• MDR Text Key: 320589909
• Report Number: 9610595-2023-11276
• 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: 09/07/2023

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: 07/10/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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