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 Type  malfunction  

Event Description

It was observed that during the device inspection, the flex deflectable videoscope exhibited that due to damage on charged coupled device unit in endoscope connector, color tone of the image was not proper (image was magenta or green only).The flex deflectable videoscope also exhibited an image noise occurred during angle operation (the image was invisible).There were no reports of patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field h3 and h6.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, the definitive root cause could not be determined.However, it is likely that irregular color tone of image (image was magenta or green) and noise during the angulation operation was caused due to 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.The following is included in the instructions for use (ifu): instructions, operation manual, chapter 3 ¿preparation and inspection¿, section 3.8 ¿inspection of the endoscopic system¿.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: 19001588
• MDR Text Key: 339117181
• Report Number: 9610595-2024-06612
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170434662
• UDI-Public: 04953170434662
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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: Other
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2018
• 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