MAUDE Adverse Event Report: Black Diamond Video, Inc. Vividimage 4K; Vividimage 4K Surgical Display

Model Number	RLM314K2
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction

• Brand Name: Vividimage 4K
• Common Device Name: Vividimage 4K Surgical Display
• 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 ; +1(440)259-7401
• MDR Report Key: 50874093
• Report Number: 3008776287-2026-00689
• Device Sequence Number: 10715806
• Product Code: KQM
• UDI-Device Identifier: 00724995195106
• UDI-Public: (01)00724995195106
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: RLM314K2
• Device Catalogue Number: RLM314K2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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