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

Model Number OEV321UH

Device Problem Poor Quality Image (1408)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation.During evaluation, it was observed, the device had no image due to lcd panel failure, due to poor contact of lcd panel, there was an image artifact, the front panel was worn out, scratch marks on the front panel.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.

Event Description

The customer reported to olympus that the 4k uhd lcd monitor was defective (green stripe was noted on the display) and the panel needed to be replaced.There was no harm or user injury reported due to the event.

Event Description

The reported event (green stripe / lcd image issue) was found during an internal checkup.No procedure or patient was affected.

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 3 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the green stripe and the distorted image was caused by a bad contact of the lcd panel.The final root cause of this event was unable to be identified.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: 16786798
• MDR Text Key: 313740860
• Report Number: 3002808148-2023-04007
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170418723
• UDI-Public: 04953170418723
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: 04/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2020
• 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