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

Model Number PCF-H290I

Device Problems Partial Blockage (1065); Failure to Clean Adequately (4048)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

The customer reported that clogging in the forceps channel "prevented anything from passing through" the flex video scope during a polypectomy.The procedure was completed with the same device.There were no reports of patient harm.The device was returned to olympus for evaluation and testing.Foreign objects in the forceps channel and foreign objects in the nozzle were discovered.This medical device report (mdr) is being submitted to capture the reportable events found during evaluation.

Manufacturer Narrative

According to the customer, the device was not cleaned, disinfected, and sterilized the product before it was sent in for repair.The device was returned to an olympus repair facility, and an evaluation of the device was performed.Upon inspection and testing of the unit, foreign objects in the forceps channel and foreign objects in the nozzle, caused by insufficient cleaning, were discovered.In addition, the up/down knob was deformed, causing a loss in the water seal; a stretched angle wire caused the up direction and the play of the up/down knob to be less than standard; a chipped a-rubber; a clogged channel tube prevented the suction function from working; scratches on the up/down knob and fe lever; and a cracked light guide lens were discovered.The investigation is ongoing; if additional information becomes available, this report will be supplemented accordingly.

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 material found in the instrument channel and in the nozzle could not be identified and a definitive root cause of the issues could not be determined, as there was no device deformation that could result in the retention of foreign material and it is unknown if device reprocessing was being performed in accordance with the ifu.The event can be detected/prevented by following the instructions for use which state: chapter 3 preparation and inspection, section 3.3 inspection of the endoscope and section 3.8 inspection of the endoscopic system.Inspection of the endoscope ¿1.Inspect the control section and the endoscope connector for excessive scratching, deformation, loose parts or other irregularities¿.Inspection of the instrument channel ¿1.Insert the endo-therapy accessory through the biopsy valve.Confirm that the endo-therapy accessory extends smoothly from the distal end.Also make sure that no foreign objects come out of the distal end¿.¿2.Confirm that the endo-therapy accessory is withdrawn smoothly from the biopsy valve¿.¿8.Inspect the air/water nozzle at the distal end of the endoscope for any irregularities such as abnormal swelling, bulges, and dents¿.Inspection of the objective lens cleaning function inspection of air/water feeding function ¿1 keep the air/water valve¿s hole covered with your finger¿.¿2 depress the valve.Observe the endoscopic image and confirm that water flows on the entire objective lens¿.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: 17054479
• MDR Text Key: 317057825
• Report Number: 9610595-2023-08346
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H290I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2014
• 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
• Treatment: CLV-290 SN# UNKNOWN; CV-290 SN# UNKNOWN