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.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Conclusions based on investigation results on the reported phenomenon described below: the front panel flashes.Failure of the dp substrate has been confirmed.It was presumed that the failure of the dp board was caused by the aging of some devices on the board.12 years or more have passed since the delivery of the subject device.Poor connection of the scope connectors (scope connectors socket wear).It has been more than 12 years since the delivery of the device, and it was presumed that failure was caused by the wear of video connectors received by the use of the device for a long time.Abnormal appearance (damage pc card reader, rust on pip terminals).More than 12 years have elapsed since the delivery of the device, and it was presumed that the eject button was damaged by breakage of the pc card reader eject button due to long-term use or by application of excessive force by the user.As for rust on the pip terminal, it is speculated that it was caused by long-term use or by leaving the pip terminal wet by the user.Olympus will continue to monitor complaints for this device.

• 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
• 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
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1