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

Model Number CV-180

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Event Description

It was reported to olympus, the image was freezing on the screen.It is unknown where this malfunction occurred.However, it was reported there was not any patient involved in the event.

Manufacturer Narrative

In speaking with olympus technical support, the customer stated they were having intermittent issues with the image freezing on the screen which has happened at least 10 or 12 times in the past.The customer has been able to clear the issue with swapping out the equipment or scopes but not able to pinpoint their issue.The customer was advised to swap out the maj-1430 scope connector and also re-seat the maj-1933 to resolve the issue.The customer was not able to troubleshoot at that time, but stated the scope was working for now.Additional attempts to retrieve additional information from the customer regarding issue resolution were unsuccessful.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the probable cause is likely the power supply to the video cables, monitors, and facility.The same phenomenon occurred in the combinations of processors and scopes other than the device in question.

• 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: 12100178
• MDR Text Key: 280577807
• Report Number: 8010047-2021-08260
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1