MAUDE Adverse Event Report: STERIS CORPORATION S40; STERILANT

Model Number	S4000
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported prior to a patient procedure that the bar codes on their s40 sterilant were "blurry" and "smeared" and were unable to be read by the bar code scanner.Report of procedure postponements as instruments were not able to be processed for use in procedures.No report of injury.
Additional Manufacturer Narrative
The s40 sterilant subject of the reported event is being returned to steris for evaluation.Investigation in progress.A follow-up report will be submitted when additional information becomes available.

• Brand Name: S40
• 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 ; 4402597401
• MDR Report Key: 25110549
• Report Number: 3003950207-2026-00013
• Device Sequence Number: 21163767
• Product Code: MED
• UDI-Device Identifier: 00724995090722
• UDI-Public: (01)00724995090722(10)322AF07185
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K251666
• 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): 05/07/2026

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: S4000
• Device Catalogue Number: S4000
• Device Lot Number: (10)322AF07185
• 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: 04/07/2026
• Initial Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 01/12/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown