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

Model Number LTF-S190-5

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304); Poor Quality Image (1408); Communication or Transmission Problem (2896)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the endoeye flex deflectable videoscope, during the pre-use inspection, when the facility staff turned on the power, a scope communication erro code of e216 occurred, and noise was generated to the extent that the image could not be seen.Completed by replacing with similar equipment.There is no report of patient harm or injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction.

Manufacturer Narrative

E.1.Establishment name listed in its entirety:(b)(6) hospital.The device was returned to olympus.The customer¿s allegation could not be confirmed as the evaluation is pending completion.Upon intake, when the power was turned on, error code (e216) occurred and there was noise to the extent that the image could not be seen.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 report is being supplemented to provide additional information based on the legal manufacturer's final 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 event was unable to be identified.It is likely that mechanical stress accumulated in the charged coupled device electronics and imaging cable due to repeated use stress and excessive bending during handling (bending more than when operating at an angle).Since it was destroyed, it is likely that a temporary contact failure may have occurred, but further analysis was difficult and the cause could not be determined.Also, as an example, the twisting of the imaging cable and the disordered arrangement of the built-in items hindered the advance and retreat of the built-in items, including the imaging cable.A temporary contact failure has occurred in the electrical circuit of the image sensor unit at the tip of the cable itself and the cable connected to it due to the applied tensile stress.The device was evaluated where no abnormalities were found that could have caused or contributed to the event.The event can be detected/prevented by following the instructions for use which state: "chapter 3 preparation and inspection 3.8 inspection of functions in combination with related equipment [inspection of endoscopic images] check if normal light observation images and nbi observation images are displayed normally." 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: 16837234
• MDR Text Key: 314362340
• Report Number: 9610595-2023-06890
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310355
• UDI-Public: 04953170310355
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2018
• 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