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

Model Number OEV321UH

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

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

Event Date 09/10/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The image artifact was found to be due to poor contact of the liquid crystal display (lcd) panel.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the monitor had vertical stripes.The issue was found during the middle of a diagnostic colonoscopy procedure that was completed with the same device without delay.The patient was sedated; however, there was no patient harm.The device was returned for evaluation.During the device evaluation, there was no image and green stripe on the display.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

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.It has been over 2 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 that the issue of the image issue occurred from a failure in the liquid crystal display panel.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: 18177228
• MDR Text Key: 329022881
• Report Number: 3002808148-2023-13127
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170418723
• UDI-Public: 04953170418723
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K220069
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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