MAUDE Adverse Event Report: STERIS Corporation S40 Sterilant

Model Number	ALYON Surgical Lighting System
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported a "residue" on their endoscopes from s40 sterilant following sterilization.Report of procedure cancellations.
Additional Manufacturer Narrative
Investigation is currently in progress.A follow-up will be submitted when additional information becomes available.

• Brand Name: S40 Sterilant
• Common Device Name: Sterilant
• Manufacturer (Section D): STERIS Corporation; 6100 heisley road; mentor OH 44060
• Manufacturer (Section G): STERIS Corporation; 6100 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50084193
• Report Number: 3003950207-2026-00018
• Device Sequence Number: 10343031
• Product Code: FSY
• UDI-Device Identifier: 00724995222857
• UDI-Public: (01)00724995222857(11)260428(17)261228(10)344AJ03056
• 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): 07/30/2026

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: ALYON Surgical Lighting System
• Device Catalogue Number: LYH12
• Device Lot Number: (10)344AJ03056, (10)331AJ09175
• 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: 07/03/2026
• Initial Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 04/28/2026
• 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