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

Model Number	RLM314K3
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found that the fiber cabling required tightening.The technician secured and tightened the fiber cabling, tested the function and operation of the vividimage surgical monitor, confirmed it to be operating to specifications, and returned the unit to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that the display on their vividimage monitor was distorted.No report of injury or procedure delay.

• Brand Name: VIVIDIMAGE 4K
• Common Device Name: VIVIDIMAGE 4K
• 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: 25508229
• Report Number: 3008776287-2026-00408
• Device Sequence Number: 21455514
• Product Code: KQM
• UDI-Device Identifier: 00724995195113
• UDI-Public: (01)00724995195113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 06/15/2026

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: RLM314K3
• Device Catalogue Number: RLM314K3
• 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: 06/22/2023
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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