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

Model Number	OEV262H
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for inspection and the reported failure was confirmed.The customer contacted olympus technical assistance center (tac) via phone.During troubleshooting the customer informed tac that during setup, device had no display on the monitor.Tac provided remote troubleshooting assistance and confirmed the reported issue.The customer subsequently reported that facility staff resolved the issue; however, the specific corrective actions taken were unknown.As no further tac assistance was required and the issue was resolved, the case was closed.The device will not be returned to olympus for evaluation.Troubleshooting was able to resolve the reported allegation.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction.No display on the monitor was due 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.
Event or Problem Description
The customer reported no display during inspection for use involving an olympus high definition liquid crystal display monitor.There was no patient involvement reported.

• 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 ; 5082077661
• MDR Report Key: 25825573
• Report Number: 3002808148-2026-24027
• Device Sequence Number: 15906196
• Product Code: FET
• UDI-Device Identifier: 04953170363498
• UDI-Public: 04953170363498
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown