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

Model Number CV-180

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus and found the patient circuit board failure caused no image.The reason for the circuit board failure is unknown.This device is an olympus asset, it was repaired and returned to asset inventory.An olympus (b)(4) capa has been opened to manage the actions related to remediation of this late mdr reporting.

Event Description

The device was returned to the olympus repair center for general inspection.During evaluation, the repair center identified the device presented no image due to a printed circuit board failure.There was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final 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, since more than 14 years have passed since manufacturing, it is likely the parts on the board have deteriorated over time due to repeated use for a long period of time.

• 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: 10900342
• MDR Text Key: 218224473
• Report Number: 8010047-2020-09420
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

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: 07/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1