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

Model Number PCF-H290ZI

Device Problems Corroded (1131); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).The device was returned to olympus for evaluation, and the customer's allegation was confirmed.During the evaluation, it was determined, that due to damage of the air/water-cylinder; water tightness was lost and due to corrosion on endoscope connector e315 (scope unsupported scope) occurred.Additionally, the evaluation revealed the following findings: distal end had a burn; plastic distal end-cover had a burn.Adhesive on bending section cover (a-rubber) had white-clouded area, adhesives around light guide lens had white-clouded area, scope connector was deformed, universal cord was sticky, scope id was not displayed, universal cord had a wrinkle, scope-connector was dirty; due to water leakage.Control unit was dirty; due to water leakage.Adhesive on bending section cover (a-rubber) had a chip; due to wear of angle wire.The play of upward/downward knob was out of the standard value; due to wear of angle wire.Bending angle in the upward direction did not meet the standard value.And scratches were found on multiple components of the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely, that the following led to the malfunction: the defect was caused; due to breakage of image sensor unit including disconnection by stress of repeated use, external factors, or handling, or that the components including ic chip and capacitor, mounted on the electric circuit board had a defect.This issue is addressed in the instructions for use (ifu): "chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system" describes the following warning: 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 the field performance of this device.

Event Description

An olympus representative reported to olympus, the evis lucera elite colonovideoscope exhibited air/water leakage from the scope connector.There were no reports of patient harm or impact associated with this event.During testing and inspection of the returned device, due to corrosion on endoscope connector e315 (scope unsupported scope) occurred.This can be attributed to water invasion in the scope connector.This medical device report (mdr) is being submitted to capture the reportable malfunction found during device evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16746180
• MDR Text Key: 313402437
• Report Number: 9610595-2023-06172
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• 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: 03/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2019
• 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