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

Model Number CV-180

Device Problems Corroded (1131); Poor Quality Image (1408); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has returned to olympus for evaluation.Preliminary findings are reported.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the user's report is confirmed.The image flickers in and out due to worn out video connector pins.The front panel is worn out with minor corrosion on the chassis.The software version is 4.0.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported while preparing an evis exera ii video system for use, it was found to have an intermittent signal causing the image to flicker in and out.There was no patient contact/impact related to this occurrence.

Manufacturer Narrative

Additional information was received from the customer on 26-feb-2021.The event occurred at the beginning of a diagnostic cystoscopy with a flexible cystoscope.There was no delay in the procedure and no anesthesia used.The same device was used to complete the procedure.There was no known patient information known as the image flickered in and out on multiple patients.No other devices were replaced during the procedure.The processor was sent in for repair.Unknown if there was any impact to the patient or procedure, if the connections or settings were checked and found to be correct, and if the electrical contacts/optical connecting parts were cleaned and if any residue was found.It was also unknown if there were any error codes or any abnormalities noted in the connecting cables.The device was inspected prior to use and no abnormalities were noted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, it is likely that the signal was interrupted due to wear of the video connector part/pins due to long-term use, causing the image to flicker.

• 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: 11302084
• MDR Text Key: 243689990
• Report Number: 8010047-2021-02431
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

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: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 02/26/2021; 03/19/2021
• Supplement Dates FDA Received: 03/09/2021; 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1