MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; LIGHTING SYSTEM

Model Number	G-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	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, a joint cover from their harmonyair g-series surgical lighting system detached and contacted the patient.The cover was immediately removed from the sterile field, and the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite and found the screw holding the joint cover was present however the rest of the cover had broken away from this section.The observed damage is indicative of user facility personnel bumping the lighting system into walls or other equipment subsequently causing damage to the joint cover.The operator manual states, "caution - possible equipment damage: do not bump lightheads into walls or other equipment.Always use handles or gripping surface when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system." the technician counseled user facility personnel on the importance of not impacting their lighting system into walls or other equipment.The technician replaced the joint cover, tested the function and operation of the device, confirmed it to be operating to specification and returned the lighting system 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: 23369230
• Report Number: 1043572-2025-00095
• Device Sequence Number: 21354524
• Product Code: FSY
• UDI-Device Identifier: 00724995207595
• UDI-Public: (01)00724995207595(11)231031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/23/2025

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: G-SERIES LIGHTING SYSTEM
• Device Catalogue Number: LG05V
• 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: 09/24/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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