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

Model Number CV-V1

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report was not returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that in an unspecified timing with the subject device, the front panel of the subject device was not worked.There was not an image intermittent problem.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for evaluation.The repair center confirmed the customer's complaint and found a faulty printed circuit board.A review of the device history record found no deviations that could have caused or contributed to the reported issue.More than 5 years have passed since the subject device was manufactured.Based on the results of the investigation, it is likely the printed circuit board components have deteriorated over time and broke down due to repeated use.As a result, the electrical connection becomes unstable and image transmission of the scope and the video processor is affected.

• Brand Name: 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: 10917087
• MDR Text Key: 218718391
• Report Number: 8010047-2020-09590
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• PMA/PMN Number: K111756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1