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

Model Number LTF-S190-5

Device Problem No Display/Image (1183)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

The customer reported the screen blacked out when the endoeye flex deflectable videoscope was angulated.The issue occurred during an unknown therapeutic procedure.Another device was used to complete the procedure.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

Establishment name: (b)(6) hospital.During device evaluation at olympus, it was found the complaint was confirmed and the issue was able to be reproduced.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

The device evaluation found the image disappeared during angulation in up and down (ud) directions due to damage on charged coupled unit (ccd) unit.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the image sensor cable buckled resulting in no image.The cause of the buckling was due to excessive stress such as excessive twisting and bending.The inspection method for the event is described as follows in the operation manual (operation): "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.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.The following non-reportable malfunctions were observed during the device evaluation: the control unit was damaged.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: 17031860
• MDR Text Key: 316478841
• Report Number: 9610595-2023-08200
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170434648
• UDI-Public: 04953170434648
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S190-5
• Device Catalogue Number: N3828033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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