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

Model Number	M-SERIES SURGICAL LIGHTING SYSTEM
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the harmonyair m-series surgical lighting system and found loose and missing hardware on the lighthead assembly.The harmonyair m-series surgical lighting system is not under a steris service contract.The user facility is responsible for all service and maintenance activities.The technician made repairs to the lighting system, tested the function and operation, and confirmed it to be operating to specifications.The harmonyair m-series surgical lighting system was returned to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that during set up for a patient procedure, an employee was moving the lighthead to their harmonyair m-series surgical lighting system and the lighthead "fell".The patient was transferred to another room, and the procedure was completed successfully following a short delay.No report of injury.

• 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: 23544744
• Report Number: 1043572-2025-00102
• Device Sequence Number: 9327416
• Product Code: FSY
• UDI-Device Identifier: 00724995165918
• UDI-Public: (01)00724995165918(11)191023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/13/2025

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: M-SERIES SURGICAL LIGHTING SYSTEM
• Device Catalogue Number: LM01N
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2019
• 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