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

Model Number LTF-S190-5

Device Problem Poor Quality Image (1408)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the flex deflectable videoscope exhibited black and white screen.The issue occurred during an unspecified therapeutic procedure which was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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 2 years since the subject device was manufactured.The customer's allegation about the monochrome screen was confirmed.Based on the results of the investigation, it is likely that due to the stress of repeated use, external factors, or handling of the device, the image sensor unit was damaged, such as disconnection, or a part mounted on the electrical circuit board, such as integrated circuit chips and capacitors was broken, which may have resulted in the subject event.However, a definitive root cause could not be determined.The following is included in the instructions for use (ifu): the instructions, operation manual, chapter 3 ¿preparation and inspection¿, section 3.8 ¿inspection of the endoscopic system¿ describes how to inspect for the subject event.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: 19056392
• MDR Text Key: 339561348
• Report Number: 9610595-2024-07197
• 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,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2024

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-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2021
• 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