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

Model Number LTF-S190-10

Device Problem Poor Quality Image (1408)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

The customer reported to olympus the endoeye flex deflectable videoscope was producing a green image.The issue was discovered during a therapeutic, laparoscopic cholecystectomy procedure which was completed using a similar device.There was a delay for an unspecified amount of time while the device was being replaced.There were no reports of patient harm or impact.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer's allegation was confirmed.Additionally, the device evaluation found the charged coupled device was damaged and the adhesive on the protective coating of the bending portion of the device had a chip.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, it is likely the cause of the event was due to breakage of the image sensor unit including disconnection by stress of repeated use, external factors, handling, or that the components including integrated circuit (ic) chip and capacitor mounted on the electric circuit board had a defect.However, a definitive root cause cannot be identified.The following information is stated in the instructions for use (ifu) ¿chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system¿: "confirm that the wli and nbi endoscopic images are normal.Before inspection, wipe the objective lens using clean lint-free cloths moistened with saline solution or sterilized water; observe the palm of your hand in the wli and nbi endoscopic images; confirm that light is output from the endoscope¿s distal end; adjust the brightness level as appropriate; confirm that the wli and nbi endoscopic images are free from noise, blur, fog, or other irregularities; turn the angulation control levers slowly in each direction until it stops; 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: 16824982
• MDR Text Key: 314109521
• Report Number: 9610595-2023-06799
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• 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: 03/30/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2017
• 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