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

Model Number LTF-190-10-3D

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned.An evaluation of the returned device could not confirm the customer allegations ¿three dimensional images were not projected¿ and ¿image was duisturbed¿.There were few additional findings.The bending section cover and video connector had a scratch.Adhesive on bending section cover was chipped.Light guide cover glass was deformed.Video connector had a scratch.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is received.

Event Description

The customer reported to olympus that during preparation for use for a therapeutic procedure, the three-dimensional images from the endoeye flex 3d deflectable videoscope were not projected; however, two dimensional images were projected at that time.Also, the image was disturbed due to contact with the connector.The procedure was completed with the same device.There were no reports of patient harm associated with the event.

Manufacturer Narrative

This report is being submitted for additional findings during device evaluation.Upon evaluation of the returned device, it was noted that there was screen blackout and the image had an abnormal color tone (image was magenta and green only).The investigation is ongoing.A supplemental will be submitted upon completion of investigation or if any additional information is received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the image issue was due to failure of the circuit board inside the control section by stress of repeated use, external factors, or defects of the circuit board inside video connector or the system side stress of repeated use, external factors, or handling.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX 3D 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: 16673379
• MDR Text Key: 312685604
• Report Number: 9610595-2023-05533
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340710
• UDI-Public: 04953170340710
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123365
• 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,Followup
• Report Date: 06/28/2023

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-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/24/2023; 06/05/2023
• Supplement Dates FDA Received: 05/31/2023; 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2014
• 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