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

Model Number	OEV262H
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported no power during a inspection for use involving an olympus high definition lcd monitor.There was no patient injury reported.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was confirmed.This mdr was submitted during the system outage from july 22, 2026 to july 27, 2026 which may result in a delay of receipt of all of the acknowledgements.A definitive root cause could not be identified.Based on the investigation results, the most probable cause of the reported no-power issue was a failure of the gg1 board, which was found to be faulty and obsolete.Additionally, power testing confirmed that the unit shut down after approximately 5 minutes 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: 50196602
• Report Number: 3002808148-2026-27644
• Device Sequence Number: 6111128
• Product Code: FET
• UDI-Device Identifier: 04953170363498
• UDI-Public: 04953170363498
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Date Returned to Manufacturer: 07/17/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2015
• 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