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

Model Number LTF-S190-10

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

The customer reported the image did not appear on the endoeye flex deflectable videoscope.The customer noted there were momentary blackouts.The issue was improved by unplugging and plugging in the system connection part.There was no reported patient harm or impact due to this event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

Manufacturer Narrative

The subject device was returned to an olympus service center for evaluation.During inspection and testing, service confirmed there was image noise due to breakage of the image sensor and deformation/breakage of the connector.In addition, it was found there were white scratches on the image.The curved rubber adhesive part was missing, the bending angle was insufficient due to elongation of the angle wire, the video connector and video connector case were cracked, the light guide connector was deformed, and scratches were found on multiple parts of the scope.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer and the results of the investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A repair history review found the device was previously repaired on april 22, 2022.During that repair, the distal end section was repaired due to image noise, the bending section cover was scratched, the bending section cover glue was chipped, and there was insufficient angulation of the bending tube.Although it was determined that the defect was likely caused by failure of the image sensor unit, a definitive root cause of the image not appearing could not be identified.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

Event Description

Additional information received from the customer reported the image not appearing occurred prior to use in a therapeutic procedure.The name of the procedure was unknown.There was no delay to the procedure.

• 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15668626
• MDR Text Key: 306709446
• Report Number: 9610595-2022-03294
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310386
• UDI-Public: 04953170310386
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• 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