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

Model Number GIF-HQ290

Device Problems Partial Blockage (1065); Contamination (1120)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

A customer reported that their evis lucera elite gastrointestinal videoscope had no air flow.The issue was found during maintenance.There was no patient involvement.The subject device was received at an olympus service center for evaluation.During inspection and testing, remnants of white crystallized contamination believed to be an infacol (simethicone) type product was observed within the air and water channels.This report is being submitted for the malfunction found during the device evaluation [foreign material].

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.Upon inspection and testing of the unit, a clogged air/water channel and a white crystallized substance within the air/water channel were discovered.In addition, cracked and chipped light cover glasses, worn adhesive on the optical cover glass, and worn adhesive on the light cover glasses were discovered.The device failed an up angle test, an up angle and up/down & left/right angle test, a water flow and water removal test, and an electrical safety test.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation, or if additional information is provided by the customer.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).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 could not be determined.It was confirmed that foreign material was found inside the channel.Although the specific material could not be conclusively identified, it is most likely simethicone.Therefore it is also likely that the foreign material remained in the device due to a deviation from the instructions for use as nothing other than sterile water should be used for air/water feeding.It was further noted there was no damage to the area where the foreign material remained.The following information from the instructions for use (ifu) pertains to this event: gif/cf/pcf-290 series operation manual includes the detection way in chapter 3 preparation and inspection.Gif/cf/pcf-290 series operation manual includes the preventive measures in 3.8 inspection of the endoscopic system: nothing other than sterile water should be used for air/water feeding.No additives should be put into the sterile water.Non-sterile water may cause patient cross-contamination and/or infection.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 16894233
• MDR Text Key: 314811653
• Report Number: 9610595-2023-07234
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

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: GIF-HQ290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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