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

Model Number CV-180

Device Problem Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the video processor unit found the unit's front panel switches were not working and the printed circuit board was found defective.Additionally, there were minor dents and scratches on the housing/top cover.A review of the unit's history indicated the asset was last service/inspected on february 25, 2020; no problems noted.The root cause cannot be determined at this time as the investigation is ongoing.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

During a standard inspection of a customer returned asset, the evis exera ii video system center's front panel switches were not working.There was no report of any problems associated with the device and there was no patient injury or harm reported to olympus.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 8010047-2020-07626.The oem performed a device history record review and no abnormalities were found.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the investigation results, it is speculated that the device has been produced for more than 14 years, and that the pc card substrate has deteriorated due to repeated use for a long period of time, resulting in failure of the printed circuit board and no image condition.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: 10672924
• MDR Text Key: 223663230
• Report Number: 8010047-2020-07626
• Device Sequence Number: 1
• Product Code: FAJ
• 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
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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: No Information
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1