MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; 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	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the sterilizer and found that the head of one of the bolts securing the ck-5 valve had broken.The technician found that the user facility's water pressure was higher than normal which may have contributed to the reported damaged to the ck-5 valve.The user facility is responsible for ensuring that the facility water pressure remains within the sterilizer's operating specifications.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 replaced the necessary components and adjusted the water pressure.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that their amsco 400 sterilizer was leaking water.No report of injury.

• Brand Name: AMSCO
• Common Device Name: 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: 24369667
• Report Number: 3005899764-2026-00014
• Device Sequence Number: 14681090
• Product Code: FLE
• UDI-Device Identifier: 00724995209537
• UDI-Public: (01)00724995209537(11)190710
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K212424
• 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): 02/17/2026

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: SR0201210311
• 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: 01/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2019
• 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