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 Date 07/19/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the endoeye flex deflectable videoscope had an image abnormality during angulation.The issue was found during preparation for an unspecified therapeutic procedure.The intended procedure was completed using a similar device.There was no report of patient or user harm associated with the event.During testing and inspection of the returned device, it was discovered that the charge coupled device (ccd) unit in the endoscope connector, the image tone was abnormal (magenta).This report is being submitted to capture this reportable malfunction which was identified during the evaluation.

Manufacturer Narrative

During the evaluation, the specified resolving power was not obtained, error code e311 was displayed, and there was image noise, due to the damaged ccd unit.The distal end cover had a scratch, switch buttons 1 and 3, and the video cable cover, had scratches.The video connector had a crack.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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, it is likely that the reportable events occurred since the image sensor cable was kinked within the bending section of the insertion section.It is likely that the cause of the kink of the image sensor cable was excessive twisting, bending, or other stress that exceeded expectations.The event can be prevented by following the instructions for use (ifu) which state: "chapter 3 preparation and inspection 3.8 inspection of the endoscopic system in the operation manual.[inspection of the endoscope] confirm that the wli (white light imaging) and nbi (narrow band imaging) 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 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: 17560979
• MDR Text Key: 321348958
• Report Number: 9610595-2023-11786
• 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: 10/12/2023

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: 07/25/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• 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