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

Model Number	HEXAVUE SCC 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	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the monitors to their hexavue custom room rack were frozen resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
The investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.

• 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: 25845993
• Report Number: 3008776287-2026-00546
• Device Sequence Number: 16108328
• Product Code: KQM
• UDI-Device Identifier: 00724995198503
• UDI-Public: (01)00724995198503(10)1.8.0
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/16/2026

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 SCC 1.0
• Device Catalogue Number: XQHILCC1
• Device Lot Number: (10)1.8.0
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/16/2026
• 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