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 Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Evaluation of the device determined that the video was flickering.Further inspection found that the device video connector was worn out and the pip connector was corroded.The identified broken parts were replaced and device was repaired.Once completed, functional testing including the electrical testing was performed.The device passed all testing specifications and no issue was observed.As stated on the ifu and as a preventive measure, the user manual states : in case of video system center failure or malfunction, always keep another video system center in the room ready for use.Do not connect or disconnect the endoscope connector while this video system center is turned on.Connecting or disconnecting the endoscope while this video system center is on may destroy the ccd.Turn the video system center off before connecting or disconnecting the endoscope.

Event Description

It was reported that during preparation for use, the device video image is flickering.There was no patient involvement on this report.No user harm or injury reported due to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.It was reported that during preparation for use, the device video image is flickering the root cause has not been identified.The probable cause is as follows: based on the evaluation findings of ¿corrosion of connectors due to wear of video connectors¿, it is presumed that abnormal communication between the endoscope and the video processor occurred due to corrosion of the video connector of the device, resulted in the reported phenomenon.

• 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: 10028953
• MDR Text Key: 209225449
• Report Number: 8010047-2020-02490
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• 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: 04/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1