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

Model Number CV-180

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

Device was received for evaluation. Evaluation determined that the reported issue was found to be due to a faulty circuit board. In addition, the video connector was observed to be worn out and the pip cable was found corroded. This caused poor connection. The pc card reader was damaged and minor wear on the front panel and rear panel were observed. The identified parts were replaced, device was repaired. The software was upgraded. Once completed, the device was tested and passed all testing criteria and specifications. Based on evaluation findings, the reported issue was confirmed. The issue was due to a defective circuit board attributed to electrical component failure.

Event Description

It was reported that the device was found with flashing lights when it was turned on. No further details were provided regarding the event. There was no patient involvement on the report.

• 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: 10320622
• MDR Text Key: 223501880
• Report Number: 8010047-2020-04772
• 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: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/24/2020
• 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?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 07/25/2007
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse