MAUDE Adverse Event Report: Black Diamond Video, Inc. HexaVue Custom Room Rack

Model Number	HexaVue SCC 1.0
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a patient procedure their hexavue custom room rack would freeze when attempting to capture video.The procedure was completed successfully.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the hexavue custom room rack and found that the sound card required replacement.To resolve the issue the technician replaced the sound card, tested the function and operation of the unit, confirmed it to be operating to specification, and returned the unit to service.No additional issues have been reported.

• Brand Name: HexaVue Custom Room Rack
• 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 ; +1(440)259-7401
• MDR Report Key: 50485677
• Report Number: 3008776287-2026-00606
• Device Sequence Number: 21383236
• Product Code: KQM
• UDI-Device Identifier: 00724995198503
• UDI-Public: (01)00724995198503(10)2.2.0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HexaVue SCC 1.0
• Device Catalogue Number: XQHILCC1
• Device Lot Number: (10)2.2.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/27/2026
• 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