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

Model Number CV-180

Device Problems No Display/Image (1183); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.On a follow up communication with the technical support engineer, the reporter conveyed that the reported issue was resolved.The reporter did not provide further information as to how the issue was resolved, however, it is likely that the issue was resolved by changing to a new cable as the reporter stated during the incident and troubleshooting that he will obtain another video cable and will report back to the technical support engineer if he was able to resolve the issue.To date there are no other issues reported regarding the incident.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that cv-180 device release switched button was not working correctly.According to the reporter while attempting to perform the troubleshooting and pulled up the device menu, the user was unable to view the image on the procedure monitor.Per the user he was on the correct input utilizing the composite output of the video system to the lcd monitor oev-262h input when the no image occurred.There was no patient involvement reported on this event.No user impact or injury reported due to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).Please see updated sections: g4, g7, h2, h3, h4, h6 and h10.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue was identified.It was confirmed that the event was resolved by the customer replacing the video cable with another video cable.The event was caused by some kind of failure in the video cable.There was no issue with the subject device.As stated on the instruction for use states: 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 apply excessive force to the camera cable of the camera head by bending, stretching or crushing it.Also do not pull a bundle of camera cables, as this may cause internal wire disconnection.Do not connect or disconnect the endoscope connector while this video system center is turned on.Connecting or disconnecting the endoscope while this video system center is on may destroy the ccd.Turn the video system center ¿of before connecting or disconnecting the endoscope.".Olympus will continue to monitor complaints for this device.

• 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: 10078350
• MDR Text Key: 208362179
• Report Number: 8010047-2020-02838
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1