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

Model Number CV-180

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

There is no additional information for this event as yet.Upon troubleshooting, the issue was resolved by first removing the maj-1462 and then connecting the sdi cable from the device to the monitor.The input on the monitor was changed from rgb to sdi and the color issue was resolved.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 any information becomes available.

Event Description

As reported for this event, the device displayed a yellow tint image on the monitor.There is no reported harm or adverse impact to any patient.

Manufacturer Narrative

The device is not returned.As such, an actual device evaluation is not performed.An evaluation is done based on historical records.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.The reported issue was that the device displayed a yellow tint image on the monitor.The customer removed the monitor cable (maj-1462) and connected the sdi cable from the cv-180 to the oev-261h.When changing the input source from rgb to sdi, the problem was resolved.Root cause of the event cannot be determined, since the customer did not return the device as the image issue was resolved.Since the problem was resolved when connection to the monitor was changed from rgb to sdi, it could be possible that there was a problem in rgb signals.More than 14 years have passed since the subject product was delivered, and the dp board could have failed because the parts on the board broke down by repeated use for a long period, or there was no problem in the subject product and the monitor cable was broken, causing the phenomenon.Either because of board failure or because of a break in the monitor cable, a blue signal was not input into the monitor, causing the yellowish image.

• 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: 10744433
• MDR Text Key: 223852633
• Report Number: 8010047-2020-08202
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1