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

Model Number CF-HQ190I

Device Problem Corroded (1131)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the device was displaying an endoscope error on two different columns.The device was returned to service where evaluation found an e217 error.There was no harm or user injury reported due to the event.This report is being submitted for the malfunction found at evaluation.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was returned to olympus for evaluation where service confirmed the customer's complaint.Additionally, the rubber gluing was worn out, the knob had play and less angulation, the light guide tube was wrinkled, the cover lens had scratches, there was corrosion of the plug unit and switch from the connector.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 inside of the scope connector was corroded due to water invasion of the device while the user was handling the device.Then, abnormality of electronic parts occurred which led to displayed error message.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): user may detect the suggested event by handling the device in accordance with the following ifu." inspection of the endoscopic image" user may reduce/prevent occurrence of the suggested event by handling the device in accordance with the following ifu."when attaching the connector cap of the leakage tester (mb-155) to the venting connector of the endoscope, make sure that both the connector cap and the venting connector are thoroughly dry.Water on the surface of either component may enter the endoscope and could cause endoscope damage.Do not attach/detach the leakage tester while the endoscope is immersed.Attaching/detaching under water could allow the water to enter the endoscope, resulting in endoscope damage." olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA III 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: 17109650
• MDR Text Key: 317920066
• Report Number: 9610595-2023-08733
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305139
• UDI-Public: 04953170305139
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CF-HQ190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1