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

Model Number CV-180

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

During a call with tac (technical assistance center) support engineer, it was determined that the cables (maj-1430 ) and all scopes worked on the second cart.Customer was then advised to return the device for evaluation and repair, however, the subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported issue could not be determined at this time.This report will be supplemented accordingly following investigations.

Event Description

It was reported that the device is having intermittent image loss.The issue occurred during an unknown event.There was no patient involvement, no user injury reported due to the event.

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.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The subject device was not returned for evaluation.Based on the results of the investigation, it has been more than 10 years since device was manufactured.It was presumed that the reported phenomenon was due to aging deterioration occurred in any one of the image boards or receptacle unit of the device.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: 11836342
• MDR Text Key: 251162271
• Report Number: 8010047-2021-06418
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1