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 05/31/2023

Event Type  Injury  

Event Description

The olympus representative reported on behalf of the customer that during the procedure, the screen turned into a distorted color screen and an error message occurred stating to clean the connection part on the endoeye flex deflectable videoscope.There was no replaceable scope of the same type and the procedure (therapeutic appendectomy) was delayed for one hour during sterilization time.The patient¿s anesthesia was also extended for this time period.The procedure was completed with a similar device and the issue was resolved.There was no health hazard and no additional patient harm reported.

Manufacturer Narrative

The device was returned and evaluated, and the customers allegations were confirmed, an e226 error was found during image output, and an error message was displayed.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 and correction to d4.Corrected: d4 as this field was inadvertently not completed on the initial medwatch.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 the phenomenon was due to the accumulation of electrical load (stress) of repeated energization to the image sensor mounted in the image sensor unit including the electric parts mounted on the electrical circuit board, applied static electricity accidentally or the status of the electric connects became bad temporarily and it had a bad influence on the image signal output and it became unstable due to the overcurrent such as insertion or pulling while the system was on.Moreover, on the applied voltage such as overcurrent occurred due to insertion and pulling of the connector while the system was on, overcurrent from other components or electrical wiring, or adhesion such as dust or moisture at the system and the electric contacts of the video connector.However, the root cause of the phenomenon could not be specified.The event can be prevented by following the instructions for use which state: ¿chapter 3 preparation and inspection, section 3.8 inspection of the endoscopic system¿ -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: 17204394
• MDR Text Key: 317902236
• Report Number: 9610595-2023-09308
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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
• Treatment: OTV-S300/7932893
• Patient Outcome(s): Other