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

Model Number	HEXAVUE IP
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that touch panel connected to their hexavue ip custom room rack was not showing an input source.This event did not occur during a patient procedure.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the fiber cabling had become loose and required tightening.To resolve the issue, the technician tightened and secured the fiber cabling, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

• Brand Name: HEXAVUE
• Common Device Name: HEXAVUE 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 ; 4402597401
• MDR Report Key: 25553213
• Report Number: 3008776287-2026-00535
• Device Sequence Number: 10751699
• Product Code: KQM
• UDI-Device Identifier: 00724995220594
• UDI-Public: (01)00724995220594(10)2.2.0
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/18/2026

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 IP
• Device Catalogue Number: XQHPILCC
• Device Lot Number: (10)2.2.0
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/18/2026
• 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