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

Model Number PCF-H290ZI

Device Problem Corroded (1131)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.And the customer's allegation was confirmed.The device evaluation revealed the following findings: plastic distal end cover (c-cover) had a dent; adhesive around light guide lens was peeled; adhesive around objective lens was peeled; paint on suction-cylinder was peeled; universal cord was sticky; scope id was not displayed; scope-connector was dirty due to water leakage; control unit was dirty due to water leakage; adhesive on bending section cover (a-rubber) had white-clouded area; adhesive on bending section cover (a-rubber) had a crack; adhesive on bending section cover (a-rubber) had a chip; due to wear of angle wire, bending angle in the upward direction did not meet the standard value; due to wear of angle wire, the play of upward/downward knob was out of the standard value; universal cord had a wrinkle; and scratches were found on multiple components of the device.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus, the air/water flow system on the evis lucera elite colonovideoscope had air/water leakages.There were no reports of patient harm or impact associated with this event.During testing and inspection of the returned device, an e315 (scope err unsupported scope) occurred, due to corrosion on endoscope connector.This medical device report (mdr) is being submitted to capture the reportable malfunction found during device 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, it is likely that the event occurred due to breakage or disconnection of the image sensor unit due to stress of repeated use, external factors or handling, or failure of the parts mounted on the electrical circuit board such as integrated circuit chips and capacitors.The event can be prevented by following the instructions for use which state: "chapter 3, section 3.8 inspection of the endoscopic system.[inspection of the endoscopic image].Confirm that the wli (white light imaging) and nbi (narrow band imaging) endoscopic images are normal.1 observe the palm of your hand using the wli and nbi endoscopic images.2 confirm that light is output from the endoscope¿s distal end.3 confirm that the wli and nbi endoscopic images are free from noise, blur, fog, or other irregularities.4 turn the up/down and right/left angulation control knobs slowly in each direction until they stop.5 confirm that the wli and nbi endoscopic images do not momentarily disappear or display any other irregularities." 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: 16782325
• MDR Text Key: 313717860
• Report Number: 9610595-2023-06460
• 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,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H290ZI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2020
• 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