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

Model Number CV-180

Device Problem Loss of Power (1475)

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

Event Date 08/24/2022

Event Type  malfunction  

Event Description

A user facility reported to olympus that during "routine morning inspection," the device was powered on and then the device lost power.There was no patient involvement, associated with the event, reported to olympus.

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem was confirmed and the cause isolated to a power unit failure.Additional evaluation findings are as follows: 1.) dust accumulation inside the unit; 2.) inside harness has poor appearance due to rust noted; 3.) wear of the video connector socket noted.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h4, h6, and h10.Additionally, wires were rusty, the receptable was found to be loose, minor scratch on the top cover, minor corrosion on the rear panel, minor scratch on the front panel, minor scratch on the chassis, and the front panel was yellowish; however, these defects are not considered severe enough to cause a potential adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely due to a faulty power supply unit.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: 15465146
• MDR Text Key: 306318476
• Report Number: 3002808148-2022-02279
• 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,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2011
• 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