MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; STEAM STERILIZER

Model Number	AMSCO 400 STEAM STERILIZER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their amsco 400 sterilizer was leaking water.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the auto-flush drain was clogged and found water passing through the solenoid valves.The technician found that the user facility's water pressure was higher than normal which may have contributed to the reported damage to the drain and valves.The amsco 400 sterilizer operator manual states (3-1), "water pressure - water ejector specification is 30 to 50 psig (2.1 to 3.5 bar), dynamic." the operator manual further states (3-1), "water pressure supplied must be within specifications as shown on the equipment drawing.If pressure is too high, a regulator must be installed.If water pressure is too low, equipment performance will be affected." to resolve the issue, the technician installed a water pressure regulator and replaced the solenoid valves.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: STEAM STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24815799
• Report Number: 3005899764-2026-00027
• Device Sequence Number: 13160457
• Product Code: FLE
• UDI-Device Identifier: 00724995209537
• UDI-Public: (01)00724995209537(11)241003
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/08/2026

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: AMSCO 400 STEAM STERILIZER
• Device Catalogue Number: SR0201110311
• 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: 03/09/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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