MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER

Model Number CV-180

Device Problems Corroded (1131); Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been evaluated by olympus.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.Physical evaluation of the complaint device reveals: there is heavy corrosion on top cover and front panel chassis.The user's report is confirmed.There are worn out pins inside the video connector causing flickering image.The software version needs updated.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during an unspecified procedure using an evis exera ii video system center, the image was flickering.There was no patient impact related to this occurrence.

Manufacturer Narrative

This report is being updated to provide investigation results.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: do not clean the videoscope cable socket, the terminals and the ac mains power inlet.Cleaning them can deform or corrode the contacts, which could damage the video system center.Conclusion: more than 13 years have passed since the subject device was manufactured, and it is presumed that the lock mechanism of the video connector socket was worn away and failed due to repeated use for a long period.Because of the failure, it is presumed that the connection of the video connector was unable to be fixed and became loose, and the electrical contacts of the connector became unstable and the image transmission between the endoscope and the video processor was hindered, and then the image flickered when the endoscope cable was moved.It is presumed that the corrosion found on the device occurred because the user left the device wet.

• Brand Name: EVIS EXERA II VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11474286
• MDR Text Key: 239460120
• Report Number: 8010047-2021-03652
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1