MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q260J

Device Problem Poor Quality Image (1408)

Patient Problems Chest Pain (1776); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was returned to olympus for evaluation, which revealed a wrinkled insertion tube, leakage in the channel tube, worn switch, scratched light guide tube, a slightly scratched objective lens, and a damaged charge coupled device (ccd) unit.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause for this issue was not established.The following are the probable causes: the entire image was blurred due to damage to the ccd unit, the entire image was blurred due to a sliding error of the movable l-range that occurred in the zoom scope, blurring of the entire image occurred within the allowable range, or the entire image was blurred due to damage or deformation of the connector.The user may be able to reduce or prevent the occurrence of the event by following the instructions for use: "operation manual.Inspection of the endoscopic system.Operation manual.Important information ¿ please read before use: warnings and cautions".Olympus will continue to monitor field performance for this device.

Event Description

The user facility reported to olympus that this evis lucera gastrointestinal videoscope exhibited a blurry image, and a blocked nozzle during a gastroscopy.In addition, the angle was adjusted several times since it could not reach the ideal direction.The procedure was prolonged; however, there was no injury or patient harm during the procedure.The patient also had chest pain for five days.

Event Description

Additional information was received.The customer reported to an olympus representative that the patient's chest pain occurred prior to the procedure.Gastroscopy was reportedly performed because of the chest pain.The procedure was prolonged for a few minutes, but no additional treatment was required.The patient was discharged without further incident.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the customer as reflected in b5.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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: 16378816
• MDR Text Key: 309590331
• Report Number: 9610595-2023-02533
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q260J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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
• Treatment: CV-290 WITH AN UNKNOWN SERIAL NUMBER
• Patient Outcome(s): Other