MAUDE Adverse Event Report: STERIS SAS HEXALUX EXAMINATION LIGHT

Model Number	HEXALUX CEILING MOUNT
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the spring arm on their hexalux examination light detached at the end of a patient procedure.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the lighting system and found that the examination light was improperly installed.As a result of improper installation, the retaining ring became loose causing the spring arm to detach.The subcontractor responsible for installation was retrained on the proper installation procedure.The technician reinstalled the lighting system, tested it, confirmed it to be operating according to specification, and returned it to service.As a precautionary measure, the technician inspected all the other hexalux lighting systems at the user facility to confirm proper installation and operation.No additional issues have been reported.

• Brand Name: HEXALUX EXAMINATION LIGHT
• Common Device Name: EXAMINATION LIGHT
• Manufacturer (Section D): STERIS SAS; 116 avenue de magudas; le haillan, bordeaux 33185 ; FR 33185
• Manufacturer (Section G): STERIS SAS; 116 avenue de magudas; le haillan, bordeaux 33185 ; FR 33185
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18067708
• Report Number: 3011221111-2023-00003
• Device Sequence Number: 12683772
• Product Code: KZF
• UDI-Device Identifier: 00724995167806
• UDI-Public: (01)00724995167806(11)220531(21)207512
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/03/2023

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: 10/05/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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