MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 4K UHD LCD MONITOR

Model Number OEV321UH

Device Problems No Display/Image (1183); Failure to Power Up (1476)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

Customer reported that they had a patient on the table and the slave monitor was not working as it should be.According to the reporter, this caused a delay of around 10 minutes whilst they were on the phone with the customer care.In a follow communication, it was confirmed that the issue was first noticed when the patient was under ga (asleep) while having the procedure.According to the report customer had to wheel the patient to another room which had both monitors working.The issue occurred during a diagnostic colonoscopy procedure.According to the report, there was delay of about fifteen (15) minutes in the procedure.There was no patient harm or injury reported.The intended procedure was completed using a similar device.No harm was reported, no user injury reported.

Manufacturer Narrative

The subject device was not returned for evaluation.In a follow up communication with olympus territory manager (tm) who visited the customer site, it was reported the issue with the customers monitor was resolved.The tm reported that the issue was not with the monitor.The customer turned off the endo-aid (an application for computer-aided detection powered by ai ) which in turn cut the image from the cv-1500 to oev unit.According to the tm, it was determined to be human factors and not the equipment, stated that the team have been trained previously on not turning the endo-aid off.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the monitor issue was the user not turning the power on.The monitor issue might have been prevented by following the description in the instruction manual.The product has a function to assist with detecting mucosal abnormalities.Olympus will continue to monitor field performance for this device.

• Brand Name: 4K UHD LCD MONITOR
• Type of Device: MONITOR
• 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: 16588863
• MDR Text Key: 312216145
• Report Number: 3002808148-2023-02813
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170418723
• UDI-Public: 04953170418723
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K220069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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: OEV321UH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• 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: CV-1500 VIDEO SYSTEM