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

Model Number	HEXAVUE-SLC 1.0
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the hexavue custom room rack subject of the event and confirmed the usb-x did not fully reboot after a firmware version update and required a full reboot prior to use.It was learned that user facility personnel had already conducted a full system reboot prior to the technician's inspection.The technician confirmed the hexavue custom room rack was properly rebooted, tested the system and confirmed it to be fully operational, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure the usb-x keyboard extender to their hexavue custom room rack was not working properly and required a reboot.The procedure was completed successfully.No report of injury.

• Brand Name: HEXAVUE
• Common Device Name: HEXAVUE 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: 23968062
• Report Number: 3008776287-2026-00015
• Device Sequence Number: 4888237
• Product Code: FTA
• UDI-Device Identifier: 00724995198497
• UDI-Public: (01)00724995198497(11)211110(10)R213140281
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/05/2026

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)R213140281
• 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: 03/18/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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