MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; SURGICAL LIGHTING SYSTEM

Model Number	G-SERIES SURGICAL 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	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a screw from the canopy of their harmonyair g-series surgical lighting system fell into the sterile field.The sterile field was re-established and the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the unit.Upon the technician's arrival, the user facility biomed had already re-installed the screw.The lighting system subject of the event was installed in 2017 making it approximately 8 years old and is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The harmonyair g-series surgical lighting system operator manual states, "warning peronal injury hazard and/or equipment damage hazard safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in addition to the regular performance of routine maintenance.Contact steris service engineering to schedule preventive maintenance." the technician counseled the user facility on proper preventive maintenance activities.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: 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: 23843687
• Report Number: 1043572-2025-00120
• Device Sequence Number: 9817333
• Product Code: FSY
• UDI-Device Identifier: 00724995192112
• UDI-Public: (01)00724995192112(11)171002
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 12/18/2025

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: G-SERIES SURGICAL LIGHTING SYSTEM
• Device Catalogue Number: LG11
• 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: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2017
• 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