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

Model Number CV-180

Device Problems Poor Quality Image (1408); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The referenced asset video processor was returned to the service center for evaluation.The service group found the video connector had a worn out lock latch causing loss of image when manipulating the video cable.Additionally, the rf board was defective; causing sdi signals to be out of sync.The picture in picture (pip) connector was corroded.There were scratches on the top cover and a faded front panel.The asset video processor was repaired back to specifications and returned to the inventory.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

During a standard service inspection of an asset return, the evis exera ii video processor was found to have a worn out lock latch on the video connector causing loss of image when the video cable is manipulated/wiggled.There was no report of any problems associated with the device and there was no patient injury or harm reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the worn out lock latch likely occurred due to repeated use of the device for a long period of time (over 14 years), which caused the wearing away of the lock latch of the video connector socket.This made the electrical contacts of the connector unstable, causing failure to transfer the video signals between the endoscope and the video processor, causing the loss of image.In addition, the failure of the rf board (printed circuit board) was likely caused by deterioration of parts on the board over time.The rf board is designed to produce output signals.This caused failure in the synchronization of the video signal.

• 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: 10895693
• MDR Text Key: 218001411
• Report Number: 8010047-2020-09394
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

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: Other
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1