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

Model Number CV-180

Device Problems Image Display Error/Artifact (1304); Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2020

Event Type  Malfunction  

Manufacturer Narrative

There is no additional information for this event available as yet. The device will not be returned as the issue was resolved with the correct installation of the cables. Supplemental report(s) will be filed as any information becomes available.

Event Description

As reported for this event, the device yielded an image that was tinted blue with a monitor out cable to a third-party monitor. The image issue was resolved when the sdi was used as the input to the monitor after the sdi cable was attached to the device. There was no reported patient involvement.

• 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: 10236250
• MDR Text Key: 223235581
• Report Number: 8010047-2020-03927
• 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: OTHER,USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/06/2020
• 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
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/04/2011
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse