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

Model Number CV-180

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence was executed for this device.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.The concomitant third-party monitor was an endovue nds monitor, model number sc-sx19-a1203, serial number (b)(4).

Event Description

As reported for this event, during set up the device yielded an intermittent image on the main third-party monitor.Color bars and menu were available and an image came up with the rgb cable reseating.The image intermittent issue was resolved by switching to s-video setting and rebooting the device.There was no patient involvement and no delay of the intended procedure.

Manufacturer Narrative

The device is not being returned as the issue of intermittent image was solved by switching to s-video setting and rebooting the device.Evaluation of the device is done with historical records.This supplemental report is being submitted to provide this information.The device history record review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing.Since there was no problem with the image from the s video connector and the rgb output connector and also in the digital output part, the image was output when the device was restarted, it is likely that since more than about eight years have passed since the device was manufactured and signals were not output because the sdi signal output of the image output board became unstable due to deterioration of the sdi signal output components on the image output board by long-term use.

• 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: 10373106
• MDR Text Key: 201895369
• Report Number: 8010047-2020-05330
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CV-180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1