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

Model Number	LAS0036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a patient procedure the light handle cover to their harmonyair a-series surgical lighting system detached from the light handle; the cover did not enter the sterile field.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the return of the device, a cause of the reported event could not be determined.Based on the description of the reported event, the likely cause of the reported detachment would be attributed to incorrect or incomplete installation of the cover by user facility personnel.The recommended instructions for installation of the las0036 light handle cover product is documented within the applicable steris surgical lighting system's operator manual.The relevant operator manual is provided with every steris surgical lighting system sold.A steris account manager provided in-service training on the proper installation and handling of the light handle cover.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 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: 50128628
• Report Number: 1043572-2026-00079
• Device Sequence Number: 16101155
• Product Code: FSY
• UDI-Device Identifier: 00724995217358
• UDI-Public: (01)00724995217358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/04/2026

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: LAS0036
• Device Catalogue Number: LAS0036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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