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

Model Number CV-180

Device Problems Corroded (1131); Degraded (1153); Poor Quality Image (1408)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.The evaluation confirmed the user report.There were worn out pins inside the video connector and corrosion on the picture-in-picture connector.The parts were replaced.This event is under investigation.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported there was static on the monitor when plugging in the camera for an evis exera ii video system center.This event was discovered during preparation for use.No patient involvement or impact to patient care was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) was conducted.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The cause of the reported image problem was determined to be the worn video connector pin.The root cause of the worn pin was determined to be repeated use over 10+ years.Olympus will continue to monitor the field performance of 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: 11574572
• MDR Text Key: 242445074
• Report Number: 8010047-2021-04200
• 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: 04/27/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1