MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; LIGHTING SYSTEM

Model Number	A-SERIES LIGHTING SYSTEM
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	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in process; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, a component of the control keypad on the harmonyair a-series surgical lighting system detached and fell into the sterile field.The user facility personnel re-established the sterile field resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the silicone rubber layer of the yoke control keypad had detached; however, a cause of the detachment could not be determined.To resolve the issue, the technician replaced the keypad.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: LIGHTING SYSTEM
• 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: 23647303
• Report Number: 1043572-2025-00107
• Device Sequence Number: 17349204
• Product Code: FSY
• UDI-Device Identifier: 00724995188344
• UDI-Public: (01)00724995188344(11)250225
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/25/2025

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: A-SERIES LIGHTING SYSTEM
• Device Catalogue Number: LAH04IN01
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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