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.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• 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
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device Was Involved in the Event

0 PatientS WERE 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

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 02/08/2006
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse