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

Model Number	OEV321UH
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that no image was present during inspection for use involving an olympus monitor.No patient involvement was reported.
Additional Manufacturer Narrative
The customer contacted olympus technical assistance support (tac) through an alternative channel.Troubleshooting addressed the required distance and included support from an olympus corporation of the americas (oca) sales representative.The sales representative reported that the monitor had been replaced and that they were attempting to re-pair the uwit-tx olympus transmitter and uwit-rx olympus wireless receiver.Tac referenced the instruction manual and guided the representative through the pairing process.Although the camera head lights indicated a successful connection, no image was displayed.Tac confirmed the monitor input was set to serial digital interface and recommended swapping the transmitter and receiver for further troubleshooting.The customer notified tac of the outcome.The device will not be returned to olympus for evaluation.The device was not returned to olympus for inspection, so the reported failure could not be confirmed.We could not identify a definitive root cause.The investigation did not establish the most probable cause of the complaint.If additional relevant information becomes available, we will submit a supplemental report.Olympus will continue to monitor field performance for this device.

• Brand Name: 4K UHD LCD MONITOR
• Common Device Name: 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: 50419549
• Report Number: 3002808148-2026-29595
• Device Sequence Number: 10646896
• Product Code: GCJ
• UDI-Device Identifier: 04953170418723
• UDI-Public: 04953170418723
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K220069
• 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): 08/24/2026

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: OEV321UH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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