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

Model Number CV-180

Device Problem Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2020

Event Type  Malfunction  

Manufacturer Narrative

Device has been returned for evaluation. The customer¿s complaint of front panel flashing was confirmed. The service technician observed the issue was due to a faulty dp board. Unit was functioning normally with our test dp board. In addition, a worn out video connector was causing poor connection, pc card reader was damaged, and pip cable was corroded. Parts were replaced. Minor wear on front panel and rear panel. Unit passed electrical leak test and all functional tests. All video output signals and images tested okay. Unit has up to date nbi and software version. The cause can be attributed to an electrical component failure. No further information was reported.

Event Description

The customer reported to olympus that front panel of the device was blinking. There was no patient injury reported.

• 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: 10315891
• MDR Text Key: 200483392
• Report Number: 8010047-2020-04757
• 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: HEALTH PROFESSIONAL,USER FACI
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/23/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/03/2020
• 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