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

Model Number CV-180

Device Problem Image Display Error/Artifact (1304)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

The olympus field service engineer manager reported (on behalf of the customer) that while using the evis exera ii video system center, there was an intermittent image issue.The issue occurred during the procedure, and the physician was able to complete the procedure by repowering the device (the issue did not reoccur during the duration of the procedure).There was no patient harm associated with the event.

Manufacturer Narrative

The device is expected to be returned for evaluation but has not yet been received.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

B5/event description: it was additionally reported that the issue occurred during the diagnostic procedure (gastrointestinal), there was a 3 second delay, and the patient was not under sedation at the time.

Event Description

It was additionally reported that the issue occurred during the diagnostic procedure (gastrointstinal), there was a 3 second delay, and the patient was not under sedation at the time.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's device evaluation and investigation.Based on the results of the device evaluation, the reported event was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified, nor could the phenomenon be confirmed/reproduced.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: 16051073
• MDR Text Key: 307691289
• Report Number: 3002808148-2022-05590
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 12/27/2022; 04/05/2023
• Supplement Dates FDA Received: 12/28/2022; 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2010
• 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
• Treatment: CLV-180(SN (B)(6) )/GIF-Q180(SN (B)(6) ).