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

Model Number CF-HQ290L

Device Problem Device Handling Problem (3265)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

An olympus representative reported that the evis lucera elite colonovideoscope had white crystallized contamination believed to be an infacol (simethicone) type product was evident within the air and water channels during maintenance.There was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

In addition, the following findings were noted during device evaluation: light cover glasses chipped, glasses adhesive worn, optical cover glass chipped, distal end cap damaged, distal end adhesive worn, aspiration housing colored ring worn, plug body leaking, plug body - production labels damaged, low angle, knobs play, and electrical safety test failed.The investigation is ongoing.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, it is likely that the device remained clogged with foreign material due to user handling.The event can be prevented by following the instructions for use (ifu) which state: "ifu: gif/cf/pcf-290 series operation manual chapter 3 preparation and inspection shows how to detect the event.Ifu: gif/cf/pcf-290 series reprocessing manual chapter 5 reprocessing the endoscope shows how to prevent the event.Operation manual_ inspection of the endoscopic system_ inspection of the objective lens cleaning function.Warning: 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 COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 17538149
• MDR Text Key: 321049352
• Report Number: 9610595-2023-11594
• Device Sequence Number: 1
• Product Code: FDF
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ290L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2014
• 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