MAUDE Adverse Event Report: BLACK DIAMOND VIDEO, INC. VIVIDIMAGE 4K; VIVIDIMAGE 4K SURGICAL MONITOR

Model Number	RLM274K
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the event to inspect the monitor and was unable to duplicate the reported event.The surgical monitor subject of the reported event was returned to steris service depot for evaluation, and the issue was unable to be reproduced.The user facility was provided with a replacement monitor.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure the image to their vividimage 4k surgical monitor loses focus and intermittently displays black lines.The procedure was completed successfully with no report of injury.

• Brand Name: VIVIDIMAGE 4K
• Common Device Name: VIVIDIMAGE 4K SURGICAL MONITOR
• Manufacturer (Section D): BLACK DIAMOND VIDEO, INC.; 503 canal blvd.; richmond CA 94804
• Manufacturer (Section G): BLACK DIAMOND VIDEO, INC.; 503 canal blvd.; richmond CA 94804
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23966587
• Report Number: 3008776287-2026-00012
• Device Sequence Number: 4746554
• Product Code: KQM
• UDI-Device Identifier: 00724995195175
• UDI-Public: (01)00724995195175(11)240911
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: RLM274K
• Device Catalogue Number: RLM274K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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