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

Model Number	OEV321UH
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.Additional information will be provided once available.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
The customer facility¿s biomedical engineer (biomed) reported to olympus, a ¿daisy chained¿ monitor flickers or completely black outs when the video processor or scope is bumped.This monitor is the device that is at the end of the ¿daisy chain¿ and receives its signal from a second monitor.According to the biomed, there is a cable that connects the two monitors together and the cable is routed more than 25 feet and goes under mats on the floor.Although there was no visible damage to the cable, the biomed stated he will order a new cable and replace it to see if it will resolve the problem.This was observed during an unspecified procedure.It was noted that a delay of less than 30 minutes occurred, however, there were no reports of patient or user injury related to this event and the procedure was completed with the same device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: b5, d9, g6, h2, h6, h11 the device was not returned to olympus for inspection and the reported failure was not confirmed.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.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
No additional information received from the customer.

• 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 ; 5082077661
• MDR Report Key: 25265167
• Report Number: 3002808148-2026-17780
• Device Sequence Number: 15754447
• Product Code: GCJ
• UDI-Device Identifier: 04953170418723
• UDI-Public: 04953170418723
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K220069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 05/23/2026
• Supplement Report FDA Received Date: 07/01/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CV-1500.; OEV321UH.; SCOPE.
• Patient Sex: Unknown