MAUDE Adverse Event Report: STERIS CORPORATION HEXALUX; HEXALUX EXAMINATION LIGHT

Model Number	HEXALUX CEILING MOUNT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their hexalux examination light partially detached while being repositioned, contacting both a patient and a user facility employee.It was reported that both the patient and user facility employee were injured; however, the extent of the alleged injuries, or any resulting medical treatment has not been provided.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the light.Based on the components present during the technician's inspection, it was concluded that a component part may have been inadvertently omitted during installation of the light.As a result, the retaining ring became loose causing the spring arm to detach.The technician responsible for installation was retrained on the proper installation procedure.The light has been removed from service pending reinstallation.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The technician replaced the unit's retaining ring and reinstalled the hexalux examination light.The technician tested the lighting system, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

• Brand Name: HEXALUX
• Common Device Name: HEXALUX EXAMINATION LIGHT
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery 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: 23832383
• Report Number: 1043572-2025-00114
• Device Sequence Number: 9288738
• Product Code: KZF
• UDI-Device Identifier: 00724995244286
• UDI-Public: (01)00724995244286
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 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: 11/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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