MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II VIDEO SYSTEM CENTER

Model Number CV-180

Device Problems Poor Quality Image (1408); Communication or Transmission Problem (2896)

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

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, the reported issue was confirmed due to a defective a pc board.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the evis exera ii video system center display white image and the device fails recognize the id.There was no patient involvement, no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on 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.It has been over 14 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the defective/faulty printed circuit board (pc board) could not be identified.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): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15154097
• MDR Text Key: 304879153
• Report Number: 3002808148-2022-00596
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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: 07/10/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2008
• 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