MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; STERILIZABLE COVER

Model Number	LAS0036
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	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The harmonyair ng silicone sterilizable cover subject of the reported event was returned for evaluation.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that during a patient procedure, their harmonyair ng silicone sterilizable cover detached from the light handle; the cover did not enter the sterile field.No report of procedure delay or injury.
Additional Manufacturer Narrative
The harmonyair ng silicone sterilizable cover subject of the reported event was returned for evaluation; the cause of the reported event could not be determined.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: STERILIZABLE COVER
• 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: 23489896
• Report Number: 1043572-2025-00099
• Device Sequence Number: 17317261
• Product Code: MDM
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: LAS0036
• Device Catalogue Number: LAS0036
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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