MAUDE Adverse Event Report: BLACK DIAMOND VIDEO, INC. HEXAVUE; CUSTOM ROOM RACK

Model Number	HEXAVUE-SLC 1.0
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found that the 4k output card required replacement.The technician replaced the output card, tested the function and operation of the monitor and hexavue custom room rack, confirmed the devices to be operating to specification and returned them to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that the monitor connected to their hexavue custom room rack was displaying a distorted image.The event did not occur during a patient procedure.No report of injury.

• Brand Name: HEXAVUE
• Common Device Name: CUSTOM ROOM RACK
• 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: 25056799
• Report Number: 3008776287-2026-00141
• Device Sequence Number: 18667209
• Product Code: FTA
• UDI-Device Identifier: 00724995198497
• UDI-Public: (01)00724995198497(10)2.1.1
• 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
• Report Date (Section B): 05/01/2026

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: HEXAVUE-SLC 1.0
• Device Catalogue Number: XQHLC1
• Device Lot Number: (10)2.1.1
• 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: 04/01/2026
• Initial Report FDA Received Date: 05/01/2026
• 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