MAUDE Adverse Event Report: STERIS SAS HEXALUX EXAMINATION LIGHT

Medical Device Problem Codes	Detachment of Device or Device Component (2907); Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in process, a follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the light spring arm to their hexalux examination light detached.The patient was not present in the room during the time of the event.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the lighting system and found that one of the components that helps support the lighting system and keep the retaining ring in place was not installed properly.The retaining ring then loosened which caused the reported event.An investigation revealed that the original installation technician did not properly install the light; this employee was retrained on the proper installation technique.The service technician replaced the light, tested it, confirmed it to be operating according to specification, and returned it to service.The technician inspected all other lighting systems at the user facility.All were confirmed 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: 18436741
• Report Number: 3011221111-2024-00001
• Device Sequence Number: 7023764
• Product Code: KZF
• UDI-Device Identifier: 00724995167806
• UDI-Public: 00724995167806
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• 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