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

Model Number CV-190

Device Problem Material Integrity Problem (2978)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

The customer reported to olympus technical assistance center (tac), the buttons of the evis exera iii video system center were not working.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The subject device has not been returned to olympus for evaluation.During troubleshooting, the customer was guided to press switch info on the keyboard, letter a was not configured and the same was noted with custom 1.Customer was then instructed on steps on how to change the setting.The investigation is ongoing, and a 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 updates to h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.The device was not returned for evaluation.However, based on the results of the investigation, it¿s probable the buttons did not work on the keyboard due to a setting mistake made by the user.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this 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: 16241484
• MDR Text Key: 309310744
• Report Number: 3002808148-2023-00789
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 04/10/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2014
• 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