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

Model Number CV-180

Device Problems Image Display Error/Artifact (1304); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information is not yet available for this event.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not available.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that the front panel and keyboard were not functioning.This is attributed to the faulty power supply.In addition were found, worn out lock latch on video connector causing loss of image when wiggle the pigtail and corroded pip connector.

Event Description

As reported for this issue, during preparation for use for an unknown procedure all the device indicators on the front panel were stuck in on position and could not be reset by powering the device off and on.There is no patient involvement and no harm reported to any patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h4, and h10.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.Since 14 years and more have passed since the delivery of the device, it is likely that parts of the power supply unit deteriorated over time due to repeated use for a long period, and the power supply unit failed.It is speculated that the failure of the power unit resulted in an inability of the front panel and the cp substrate controlling the keyboard to be supplied correctly and that the front panel and the keyboard were no longer functioning.Since 14 years and more have passed since the delivery of the device, it is likely that the lock latch of the video connector receiver was worn out due to repeated use for a long period of time, resulting in a failure.This possibly resulted in instability of the electrical contacts of the connectors, which interfered with image transmission between the scope and the video processor, resulting in image disappearance.It is likely that the corrosion occurred when it was used in a humid environment for a long time or when the device was left wet.

• 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: 10816745
• MDR Text Key: 224627812
• Report Number: 8010047-2020-08753
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 10/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1