MAUDE Adverse Event Report: Black Diamond Video, Inc. HexaVue; 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	08/31/2026
Type of Reportable Event	Serious 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 ; +1(440)259-7401
• MDR Report Key: 50869385
• Report Number: 3008776287-2026-00683
• Device Sequence Number: 9223548
• Product Code: KQM
• UDI-Device Identifier: 00724995198503
• UDI-Public: (01)00724995198503(10)3.3.2
• 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): 09/23/2026

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 SCC 1.0
• Device Catalogue Number: XQHILCC1
• Device Lot Number: (10)3.3.2
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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