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

Model Number CV-180

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2020

Event Type  Malfunction  

Manufacturer Narrative

The device was not returned to the service center for evaluation. The cause of the reported event cannot be determined at this time.

Event Description

The user facility reported that the monitor image was intermittently scrolling and then the screen would appear blank. There was no issues present on the provation monitor using the pc outlet 2 from rear of the cv-190. The user reportedly replaced the pigtail video cable, monitor and analog component video cable and the issue was still present. There was no patient involvement reported. Additionally, the user facility reported that the original video cable used and other replaced equipment mentioned above operated properly in a second room.

• 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: 10368773
• MDR Text Key: 202266084
• Report Number: 8010047-2020-05297
• 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
• Report Date: 08/05/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 08/05/2020
• 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

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse