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

Model Number	HexaVue IP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure an employee inadvertently bumped into their hexavue ip custom room rack which caused the rack to disconnect.When the rack was plugged back in, the system ¿locked up and appeared to shut down.¿ the procedure was completed successfully following a short delay.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and rebooted the rack.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.

• Brand Name: HexaVue
• Common Device Name: IP 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: 50156805
• Report Number: 3008776287-2026-00571
• Device Sequence Number: 18792246
• Product Code: KQM
• UDI-Device Identifier: 00724995220594
• UDI-Public: (01)00724995220594(10)3.0.0
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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

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 IP
• Device Catalogue Number: XQHPILCC
• Device Lot Number: (10)3.0.0
• 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: 08/06/2026
• 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