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

Model Number CV-180

Device Problems Erratic or Intermittent Display (1182); Electrical /Electronic Property Problem (1198); Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

The device is planned to be returned to olympus medical systems (b)(4) but has not been returned yet.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the preparation for use, the switches on the front panel did not respond and the endoscopic image disappeared intermittently.The intended procedure was diagnostic colonoscopy.In addition, the user checked the device separately and found the same issue with the device.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was evaluated at olympus medical systems india private limited (omsi) for evaluation.As a result of the evaluation, the following was confirmed.-all the leds on the front panel lit up and the front panel switches did not respond, due to the front panel failure.In addition, the image enhancement mode button worked while the exposure adjustment button was pressed, due to a cp board failure.These failure modes are mdr reportable malfunctions.-the pc card did not work due to the pc card slot failure.-no flickering of the endoscopic image was found during the 4-day observation.This may have been caused by heavy dust buildup in the device.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.The following sections were corrected: g2.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the cause of the phenomenon was confirmed to be internal dust deposition.Therefore, it was determined that communication abnormalities likely occurred due to the effects of dust, which affected the images.Also, it was assumed that the switch failed due to a failure of the board mounted on the front panel or poor continuity with the flat cable.Additionally, since a failure of the cp board was confirmed in the inspection, it was presumed that the cause of the phenomenon was due to a malfunction of the cp board.Also considered was the more than 5 years since the product was manufactured, therefore, resulting to deterioration due to repeated use.Olympus will continue to monitor field performance 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12405830
• MDR Text Key: 282228751
• Report Number: 8010047-2021-11071
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1