MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; 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	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During follow-up with user facility personnel, it was found that two additional harmonyair a-series surgical lighting systems had cracked light handles (b)(6).The three light handles are being returned to steris for evaluation.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, a small piece of the light handle to their harmonyair a-series surgical lighting system broke off and fell into the sterile field.No report of injury.

• Brand Name: HARMONYAIR
• Common Device Name: 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 ; 4402597401
• MDR Report Key: 24256611
• Report Number: 1043572-2026-00015
• Device Sequence Number: 8346394
• Product Code: FSY
• UDI-Device Identifier: 00724995200466
• UDI-Public: (01)00724995200466(11)241104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/04/2026

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: LAS01IN01A
• 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: 01/05/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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