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

Model Number LTF-S190-10

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

The olympus representative reported on behalf of the customer, there were air/water leakages on the endoeye flex deflectable videoscope.The issue did not impact a patient or other healthcare professional.There were no reports of patient harm associated with this event.The device was returned and evaluated, and the image color tone was abnormal.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned and evaluated.And the customer¿s allegation was confirmed, water tightness was lost; due to a pinhole on the bending section cover.And deformation of the light guide lens connector.Additionally, the color tone of the image was not proper, due to damage on the charged coupled device unit in the endoscope connector and corrosion on the video plug.Additional findings include the following: the bending section cover adhesive had a chip, the light guide and video connectors had a scratch, the bending section could not be fixed firmly; due to damage on the forceps elevator lever.The angle knob torque of the forceps elevator lever at engage exceeded the standard value; due to damage of the forceps elevator lever.The light guide cover glass, the protector of the video cable section, the forceps elevator lever, the angulation lever, the right/left lever, the up/down plate, control unit, and the grip all had a scratch; and switch 1 had a scratch and was dirty.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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 likely cause of the reported event is due to stress of repeated use, external factors or handling, or failure of the parts mounted on the electrical circuit board such as integrated circuit chips and capacitors.However, the root cause of the reported event is unable to be determined.The event can be detected by following the instructions for use (ifu) which state: chapter 3 preparation and inspection, section 3.8 inspection of the endoscopic system as below.[inspection of the endoscopic image].Confirm that the endoscopic image is displayed normally in wli and nbi observation.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 endoscopic image is free from noise, blur, fog, or other irregularities during wli and nbi observation.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 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: 16916267
• MDR Text Key: 315083246
• Report Number: 9610595-2023-07378
• 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: 06/12/2023

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: 04/13/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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