MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH DEFINITION LCD MONITOR

Model Number	OEV262H
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a half-screen pink display with no image displayed involving an olympus high-definition (lcd) monitor.There was no patient injury reported.
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided if available.The device was not returned to olympus for inspection however the reported failure was confirmed by technical assistance support (tac).The customer contacted olympus technical assistance support (tac) via phone.Troubleshooting steps.Troubleshooting steps included disconnecting the zeiss microscope and testing the setup with an alternate monitor and video cable to help isolate and identify the source of the issue.The customer informed tac of the event.The device will not be returned to olympus for evaluation.A root cause could not be identified.Based on the results of the investigation, the most probable cause of the malfunction was traced to component failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: HIGH DEFINITION LCD MONITOR
• Common Device Name: HIGH DEFINITION LCD 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 ; +1(508)207-7661
• MDR Report Key: 50195665
• Report Number: 3002808148-2026-27615
• Device Sequence Number: 13233422
• Product Code: FET
• UDI-Device Identifier: 04953170363498
• UDI-Public: 04953170363498
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: OEV262H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown