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 Date 05/27/2023

Event Type  malfunction  

Event Description

A customer reported that the endoscope image had noise.The issue was found while preparing the endoeye flex deflectable videoscope for a therapeutic pancreatic laparoscopy.The procedure was completed with no report of patient or user harm.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the device was manufactured.The device was returned to an olympus repair facility and an evaluation was performed.Upon inspection and testing of the unit, the reported problem of noise could not be reproduced or confirmed.Additionally, the bending section cover had a scratch and a chip, and the number of broken wires in the bending tube blade exceeded the standard value, caused by mishandling.Switch 3 had a scratch, and the video connector had a crack.Based on the results of the investigation, a root cause of the reported event could not be determined.This issue is addressed in the instructions for use (ifu): ¿chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system¿ describes the following warning. 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.

• 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: 17264107
• MDR Text Key: 318559114
• Report Number: 9610595-2023-09728
• Device Sequence Number: 1
• Product Code: GCJ
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/05/2023

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: 06/06/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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