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

Model Number CV-180

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that all the led lights on the front panel of the evis exera ii video system center turned on continuously.The event occurred during general inspection/maintenance and no procedure was involved.There were no reports of patient or user harm.

Manufacturer Narrative

The device was returned to olympus for evaluation, the customer¿s allegation was not confirmed.In addition, evaluation of the device observed the following non-reportable finding: dust inside the unit.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following field: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over thirteen (13) years since the subject device was manufactured.Based on the results of the investigation, it is not possible to establish the root cause.However, it is likely all the light emitting diodes lights on the front panel turned on continuously due to assembly failure of component which configures the front panel.The event can be prevented by following the instructions for use which state: [important information ¿ please read before use] do not apply excessive force to this video system center and/or other instruments connected.Otherwise, damage and/or malfunction can occur.Ensure proper power condition at site (proper grounding & no voltage fluctuation).During fumigation equipment must cover or moved to other area.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 (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: 17969280
• MDR Text Key: 326608724
• Report Number: 3002808148-2023-11507
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2010
• 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