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

Model Number CV-180

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus for evaluation.The reported problem could not be duplicated.The unit was tested with a clv-190 light source , maj-1411 light control cable and a gif-h180 scope.The iris functioned as intended.Brightness functioned as expected in both manual and auto mode.However, a worn lock latch mechanism was found on the video connector, causing a flickering image.

Event Description

A user facility reported to olympus that the iris was not working; it was reported that when the light was brighter it was not closing as expected.The problem, as reported to olympus, was found during a procedure.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The legal manufacturer determined the possible causes of the image interruption was deterioration due to the age of the device or user handling.As stated in the instructions for use, as a preventive measure: "do not touch the electrical contacts inside the video system center's connectors.Make sure that the video plug and its electrical contacts are completely dry before connecting the plug to the video system center.Wet equipment could cause the image to flicker or disappear.Do not clean the video scope 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.".

• 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: 10671998
• MDR Text Key: 223663200
• Report Number: 8010047-2020-07624
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 09/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1