MAUDE Adverse Event Report: STERIS Corporation HarmonyAIR; Surgical Lighting System

Model Number	A-Series Lighting System
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the broken light handle.The technician found no evidence of damage to the external surfaces.Examination of the internal base structure identified cracking of the plastic housing, with small plastic fragments and missing screws observed within the assembly.The technician replaced the light handle, tested the system, confirmed it to be operating according to specifications, and returned it to service.Based on the available information, a cause of the reported damage could not be determined.The unit was installed in 2023 and is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.No additional issues have been reported.
Event or Problem Description
The user facility reported that small pieces of plastic of the light handle to their harmonyair a-series surgical lighting system broke off during a procedure and fell into the sterile field.No report of injury.The procedure was delayed while the patient was moved to a different operating room.

• Brand Name: HarmonyAIR
• Common Device Name: Surgical Lighting System
• Manufacturer (Section D): STERIS Corporation; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS Corporation; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50588887
• Report Number: 1043572-2026-00094
• Device Sequence Number: 18504512
• Product Code: FSY
• UDI-Device Identifier: 00724995186678
• UDI-Public: (01)00724995186678(11)230906
• 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): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: LAH12IN02
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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