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

Model Number CF-EZ1500DL

Device Problems Device Reprocessing Problem (1091); Complete Blockage (1094)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation regarding the boot was not confirmed.The device evaluation found a foreign material was identified blocking the suction cylinder.In addition to the reportable malfunction, the channel cleaning brush passage was blocked.The cleaning, disinfection, and sterilization (cds) was performed by the customer.The scope was reprocessed before being sent to olympus for repair.The customer did suspected the foreign material was a seed.There was a delay to starting precleaning and the device was presoaked in detergent.The suction channel was flushed with water and the channels and channel outlets were wiped/brushed, however the brush was blocked by something in the channel.There were no reported abnormalities in the accessories used for reprocessing.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that the colonovideoscope just returned from repair and the boot no longer moved and usually does.The issue was found during a diagnostic colonoscopy, which was completed with an alternate device without delay.There were no reports of patient harm.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: a foreign material was blocking the suction cylinder.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

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 foreign matter observed clogging the suction cylinder was a solid material that appeared to be a seed(s).A definitive root cause of the issue could not be determined, as there was no device deformation observed that could contribute to the retention of foreign material, however, the facility did not conduct pre-cleaning at proper time in accordance with the ifu, therefore the issue was likely the result of improper reprocessing/user handling.The event can be detected/prevented by following the instructions for use sections below: - operation manual includes the detection method in chapter 3 preparation and inspection.- operation manual warns in ¿4.2 insertion¿ that suction channel/suction valve may be clogged by aspirating solid matter¿.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 17373555
• MDR Text Key: 320243316
• Report Number: 9610595-2023-10449
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-EZ1500DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• 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