MAUDE Adverse Event Report: STERIS SAS HEXALUX EXAMINATION 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	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the lighting system and confirmed that the light head and spring arm had detached from the ceiling mount.The technician found that one of the threaded pins was not fully inserted in the spindle resulting in the reported event.The technician is awaiting parts to make the necessary repairs.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their hexalux examination light came down from the ceiling contacting an employee's back.The unit did not completely detach from the ceiling as the electrical cable was still intact.No report of injury or procedure delay.
Additional Manufacturer Narrative
The technician repaired the lighting system, tested the function and operation, and confirmed the lighting system to be operating according to specification.The technician performed an inspection of all the user facility's hexalux lighting systems and found them to be properly installed.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: 17152626
• Report Number: 3011221111-2023-00001
• Device Sequence Number: 17540408
• Product Code: KZF
• UDI-Device Identifier: 00724995167806
• UDI-Public: 00724995167806
• 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): 06/19/2023

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: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2019
• 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