MAUDE Adverse Event Report: STERIS CORPORATION HEXALUX; SURGICAL LIGHT

Model Number	HEXALUX CEILING MOUNT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their hexalux ceiling-mounted surgical light detached and fell from the ceiling.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event.During the technician's inspection, he found that the slotted cone component, which supports the connection between the spring arm and drop tube, was missing.As a result, the other components had come loose, resulting in the reported event.The technician repaired the hexalux surgical light and confirmed all components were present and properly installed.The lighting system was returned to service.No additional issues have been reported.

• Brand Name: HEXALUX
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24955423
• Report Number: 1043572-2026-00038
• Device Sequence Number: 5264805
• Product Code: KZF
• UDI-Device Identifier: 00724995244286
• UDI-Public: (01)00724995244286(11)250609
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 04/22/2026

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: HEXALUX CEILING MOUNT
• Device Catalogue Number: EXLCEIL
• 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: 03/26/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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