MAUDE Adverse Event Report: STERIS SAS HEXALUX EXAMINATION LIGHT

Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the hexalux examination light and found that the snap ring which attaches the spring arm to the lighting system was damaged.The technician identified the root cause of the reported event to be the snap ring that secures the light's suspension arm to the ceiling mount.As the snap ring was detached, over time, this allowed for the light's suspension arm to loosen and eventually detach from the ceiling mount resulting in the reported event.The technician made the necessary repairs, tested the lighting system, confirmed it to be operating according to specifications, and returned it to service.Additionally, the technician inspected 9 other lights within the same hospital and found them to be operating according to specification.No additional issues have been reported.
Event or Problem Description
The user facility reported that the spring arm to their hexalux examination light detached, making contact to the employee and patient's head.Additionally, the patient was contacted in the forearm resulting in an injury (laceration).Medical treatment was sought and administered (wound care).No procedural delays or cancellations were reported.The procedure was completed successfully.

• 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: 19145007
• Report Number: 3011221111-2024-00002
• Device Sequence Number: 12721128
• Product Code: KZF
• UDI-Device Identifier: 00724995167806
• UDI-Public: 00724995167806
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2024

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
• 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: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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