MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE; FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-S300-10-3D

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported, the deflectable videoscope, the periphery of the 3d screen becomes blurry.The issue occurred during an the procedure, and the procedure was completed using the same set of equipment.There were no reports of patient harm.

Manufacturer Narrative

To date, the customer have not returned the device for evaluation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide further information provided by the customer, the results of the legal manufacturer's final investigation and associated h6 coding.Additionally, the following fields were corrected due to inadvertent errors in the initial report: (concomitant medical products and therapy dates), device/therapy date added.Device manufacturer date) added.(investigation findings), code "213 - no device problem found" removed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over one (1) year since the subject device was manufactured.According to the customer, the issue was no longer occurring and therefore, the device will not be returned to olympus.Based on the results of the investigation, as the issue could no longer be produced and the device was not inspected at olympus, root cause cannot be established.It is possible that the user was observing outside the viewable field of the 3d (3-dimensional) monitor.If the monitor is viewed from outside the specified range, the user may not be able to see a normal 3d image.Or one of the two objective lenses needed for 3d viewing was temporarily blocked by contamination (e.G.Body fluid or blood).If one lens view is blocked/stained, the 3d image may not be displayed correctly.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX 3D 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: 18743563
• MDR Text Key: 336881833
• Report Number: 9610595-2024-03559
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S300-10-3D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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
• Treatment: LMD-X310ST LCD MONITOR; OTV-S300 VISERA ELITE VIDEO SYSTEM CENTER