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 customer reported the scope connector label of the endoeye flex deflectable videoscope peeled off.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the color tone of the image was not proper due to damage on the charged coupled device (ccd) unit.The report is being submitted due to improper image found during evaluation.

Manufacturer Narrative

Attempts to retrieve additional information from the customer are in progress.The device was returned and evaluated by olympus.In addition to the findings, evaluation found the complaint was confirmed and the label on the video connector was peeled.Also, evaluation found the bending section cover adhesive was chipped, the connection between the insertion pipe and control unit was not secured due to looseness of the insertion pipe, and the bending cover was scratched.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

Additional information received from the customer reported the date and how the label peeling off occurred was unknown.

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.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the irregular color tone was caused by breakage or disconnection of the image sensor unit due to stress of repeated use, external factors, handling, or failure of the parts mounted on the electrical circuit board such as integrated circuit chip and capacitor.The root cause of this event was unable to be identified.The following is included in the instructions for use: ¿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.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.(see figure 3.23) adjust the brightness level as appropriate.Confirm that the endoscopic image is free from noise, blur, fog, or other irregularities during wli and nbi observation.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 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: 16245265
• MDR Text Key: 308199386
• Report Number: 9610595-2023-01328
• 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,Followup
• Report Date: 04/07/2023

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: 01/04/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 02/02/2023; 03/17/2023
• Supplement Dates FDA Received: 02/02/2023; 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2012
• 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