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); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Event Description

The distributor reported the bending section cover on the endoeye flex deflectable videoscope had a pinhole.No patient injury or procedure impact reported.During the evaluation of the device, it was noted a b30 scope communication error (no image) and an e216 scope communication error (no image) occurred.This report is to capture the reportable malfunctions of the b30 scope communication error (no image) and e216 scope communication error (no image) noted at estimation.

Manufacturer Narrative

Date of event/event: no additional information as available.The device was returned to an olympus service center for evaluation and the reported issue was not confirmed.The bending section cover adhesive was missing.The b30 scope communication error occurred due to damage to the imaging unit and the e216 (scope communication error) occurred due to corrosion of the electrical contacts in the video connector.Scratches were found on switch three (3) due to external factors.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This supplemental report is being submitted to correct the product receipt date, please see section d9 for the correct date.

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 errors b30 (no image) and e216 (no image) occurred like due to the vout signal line in the image sensor unit cable, caused by a short circuit between the core line and the shield line due to the kink.Regarding the kink of the signal line of the image sensor unit cable, it likely occurred because the image sensor unit cable's sheath was turned up and the movement of the image sensor unit cable was hindered when it was angulated.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: 15813774
• MDR Text Key: 307506046
• Report Number: 9610595-2022-04128
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2023

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/05/2022; 02/10/2023
• Supplement Dates FDA Received: 12/07/2022; 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2019
• 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