MAUDE Adverse Event Report: STERIS CORPORATION HEXALUX; HEXALUX CEILING MOUNT

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	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their hexalux examination light detached from the ceiling.No report of injury.
Additional Manufacturer Narrative
Our investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Additional Manufacturer Narrative
A steris service installation specialist arrived onsite to inspect the hexalux ceiling-mounted surgical light.The technician identified the cause of the reported event to be the snap ring that secures the light's suspension arm to the ceiling mount had been damaged.The cause of the damage could not be determined.As the snap ring was damaged, over time, this allowed for the light's suspension arm to loosen and eventually detach, resulting in the reported event.The user facility elected to have their hexalux ceiling-mounted surgical light removed from service and not repaired or replaced.No additional issues have been reported.

• Brand Name: HEXALUX
• Common Device Name: HEXALUX CEILING MOUNT
• 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: 22461877
• Report Number: 1043572-2025-00062
• Device Sequence Number: 8826859
• Product Code: KZF
• UDI-Device Identifier: 00724995244286
• UDI-Public: (01)00724995244286(11)250127
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/09/2025

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: 06/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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