MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III VIDEO SYSTEM CENTER; ENDOSCOPIC VIDEO IMAGE PROCESSING UNIT

Model Number CV-190

Device Problems No Display/Image (1183); Incomplete or Inadequate Connection (4037)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

A field service engineer reported on behalf of the customer, no image due to a video connection issue on evis exera iii video system center.The customer reported the issue to be found while preparing for use.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, the customer's originally reported issue of no image due to video connection issue was confirmed.The following additional findings were also noted: worn out video connector, faulty patient board and software version 3.01, recommended to upgrade to version 4.10.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer (identified in b5) and results of the legal manufacturer's investigation.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 investigation, the reported phenomenon (no image) occurred due to a malfunction of the patient board set (circuit board).A design change was implemented focused on the operational amplifier circuit was initiated on 16apr2018.The subject device of this report was manufactured prior to the design change.Olympus will continue to monitor field performance for this device.

Event Description

The diagnostic procedure was completed with a similar device.The issue was discovered at set up for the procedure and the scope was tested with other accessories on another device.

• Brand Name: EVIS EXERA III VIDEO SYSTEM CENTER
• Type of Device: ENDOSCOPIC VIDEO IMAGE PROCESSING UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16792832
• MDR Text Key: 314084010
• Report Number: 3002808148-2023-04080
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298622
• UDI-Public: 04953170298622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/23/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1