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	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the monitors to their hexavue focus integration systems were ¿flickering¿.No report of procedure involvement.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the hexavue focus integration systems and found the sdi cabling needed to be resecured.To resolve the issue the technician resecured the sdi cabling, technician tested the function and operation of the unit, confirmed it to be operating to specification, and returned the units to service.No additional issues have been reported.

• 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: 50485769
• Report Number: 3008776287-2026-00607
• Device Sequence Number: 10093508
• Product Code: FTA
• UDI-Device Identifier: 00724995245054
• UDI-Public: (01)00724995245054(10)2.0.18
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/27/2026

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 Focus
• Device Catalogue Number: XEHFSLC
• 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: 07/29/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2026
• 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