MAUDE Adverse Event Report: Black Diamond Video, Inc. HexaVue; HexaVue Focus Integration System

Model Number	HexaVue Focus
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a patient procedure, the touch panel connected to their hexavue focus integration system became unresponsive.The procedure was completed successfully after rebooting the system twice, causing a short delay.No report of injury.
Additional Manufacturer Narrative
The investigation of the reported event is in process.A follow-up report will be submitted once additional information becomes available.

• Brand Name: HexaVue
• Common Device Name: HexaVue Focus Integration System
• 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: 50146929
• Report Number: 3008776287-2026-00572
• Device Sequence Number: 9103112
• Product Code: KQM
• UDI-Device Identifier: 00724995245054
• UDI-Public: (01)00724995245054(10)2.0.18
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/05/2026

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 Focus
• Device Catalogue Number: XEHFSLCAMC
• Device Lot Number: (10)2.0.18
• 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: 07/09/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2026
• 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