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 02/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus, testing and inspection found that due to poor contact of the lcd panel there is an image artifact and no image.Testing and inspection confirmed the customer¿s complaint, there was a blue stripe on the display.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, it was confirmed that the cause of the image not displaying was due to a malfunction of the lcd panel.The specific root cause of the lcd panel failure could not be determined at this time.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus that there is a vertical line of broken pixels.There were no reports of patient harm associated with this event.The subject device was sent back to olympus for evaluation.During inspection and testing the following was found: liquid crystal display (lcd) panel failure.This report is being submitted for the malfunction found during evaluation (lcd panel failure).

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17011310
• MDR Text Key: 316515854
• Report Number: 3002808148-2023-05340
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170418723
• UDI-Public: 04953170418723
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K220069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• 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: 04/17/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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