MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; AMSCO 400 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	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found a bolt that secured the ck5 valve broke, allowing for water to leak from the sterilizer's piping.Upon further inspection, the technician found that the facility water pressure that entered the sterilizer was over 100 psig, above the maximum requirement, which caused the bolt to break and resulted in the reported event.To resolve the issue, the technician replaced the bolt and repaired the ck5 valve, tested the unit, confirmed it to be operating according to specification, and returned it to service.The amsco 400 series small steam sterilizers operator manual states, "section 3-1 water pressure: the water ejector specification is 2.1 to 3.5 bar (30 to 50 psig), dynamic.The supplied water pressure must be within the specifications indicated in the equipment diagram.If the pressure is too high, a regulator will need to be installed.If the water pressure is too low, the equipment's performance will be affected".While onsite the technician counseled user facility personnel on the proper water pressure requirements with their amsco 400 sterilizer.The user facility has committed to making the necessary improvements to their water pressure.A follow-up report will be submitted should additional information become available.
Event or Problem Description
The user facility reported a water leak from their amsco 400 sterilizer.No report of injury.
Additional Manufacturer Narrative
User facility maintenance has installed a water pressure regulator to ensure proper incoming water pressure to the amsco 400 sterilizer.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: AMSCO 400 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: 23850062
• Report Number: 3005899764-2025-00101
• Device Sequence Number: 9836115
• Product Code: FLE
• UDI-Device Identifier: 00724995209414
• UDI-Public: (01)00724995209414(11)230825
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: AMSCO 400 STEAM STERILIZER
• Device Catalogue Number: SR0201110011
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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