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

Model Number	M-SERIES SURGICAL LIGHTING SYSTEM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found that there was a loose component (cover) on the monitor spring arm.The cover serves as a shield/guard to prevent exposure of the inner pivot mechanism of the spring arm.The technician stated that the cover was bent and due to the damage had become dislodged from the housing position resulting in the reported event.The technician replaced the cover, tested the function and operation of the harmonyair m-series surgical lighting system, confirmed it to be operating to specifications and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained an injury to their hand while moving the monitor connected to their harmonyair m-series surgical lighting system.The employee sought medical treatment however, it is unknown the type of treatment that may have been administered.

• 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 ; 4402597401
• MDR Report Key: 25552947
• Report Number: 1043572-2026-00057
• Device Sequence Number: 10731665
• Product Code: FSY
• UDI-Device Identifier: 00724995191504
• UDI-Public: (01)00724995191504(11)190114
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/18/2026

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: M-SERIES SURGICAL LIGHTING SYSTEM
• Device Catalogue Number: LMH04
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2019
• 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