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

Model Number LTF-S190-5

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

The company representative on behalf of the customer reported to olympus, the endoeye flex deflectable videoscope exhibited communication error when the power was turned on during a therapeutic procedure.The issue persisted even after cleaning the connector.The procedure was completed with a similar device.There were no reports of patient harm associated with the event.

Manufacturer Narrative

The subject device was returned and an evaluation could not confirm the customer allegation "communication error".There were few additional findings.The adhesive of the bending section cover was chipped.Scratches were found throughout the device.Due to damage on control section, right/left lever does not move smoothly.Due to damage on lock engagement lever, bending section could not be fixed firmly.Follow up in progress to determine the details of the event.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is received.

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 root cause of the event was unable to be identified.It is likely that the circuit board inside the scope broke down and the communication with the video processor became unstable temporarily.The inspection method for the event is described as follows in the instructions for use (ifu) "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.1.Wipe the endoscope tip lens with sterile gauze moistened with saline or sterile water before inspection.2.Observe the palm, etc.With normal light observation images and nbi observation images.3.Make sure the light is coming out.(see figure 3.23) 4.Adjust the amount of light to get the proper brightness.5.Check that there are no abnormalities such as noise, blur, or cloudiness in the normal light observation image and the nbi observation image.6.Operate the angle lever of the endoscope to bend the curved part.7.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: 16833483
• MDR Text Key: 314213735
• Report Number: 9610595-2023-06880
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• 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: 04/30/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• 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