MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; HARMONYAIR A-SERIES SURGICAL 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	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the light handle of their harmonyair a-series surgical lighting system detached.The light handle did not fall but remained connected to and supported by the wires within the assembly.No report of injury or procedure delay.
Additional Manufacturer Narrative
Investigation of the reported event is in process; a follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmonyair a-series surgical lighting system and found the snap ring that helps to secure the light handle to the lighthead was not seated correctly.Upon further investigation, the technician determined that the snap ring was damaged causing it to not properly engage into its designated groove, which allowed for the light handle to rotate freely and resulted in the reported event.A replacement unit was installed.The technician tested the unit, confirmed it to be operating according to specification, and placed it in service.The device history record was reviewed and confirmed that the device was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR A-SERIES SURGICAL 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: 23621848
• Report Number: 1043572-2025-00106
• Device Sequence Number: 13029727
• Product Code: FSY
• UDI-Device Identifier: 00724995190354
• UDI-Public: (01)00724995190354(11)240820
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/21/2025

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
• Device Model Number: A-SERIES LIGHTING SYSTEM
• Device Catalogue Number: LAS000030
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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