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	Burn(s) (1757)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee had redness on their face from steam after opening the door of their amsco 400 sterilizer.The employee did not seek medical treatment and continued working.
Additional Manufacturer Narrative
Through follow up with the user facility, it was discovered that the night prior to the reported event, user facility personnel did not reopen the water supply valve after replacing inlet filters resulting in the reported event.The amsco 400 sterilizer operator manual states, "water supply valve - ensure this is in the open position before trying to operate the sterilizer." additionally, the operator manual states (pg.6-3), "warning - burn hazard: steam may be released from the chamber when door is opened.Step back from the sterilizer each time the door is opened to minimize contact with steam vapor." the sterilizer subject of the reported event is out of service and pending inspection by a steris service technician.A follow-up report will be submitted once additional information becomes available.Udi related data clarification - the device subject of the event was manufactured prior to udi compliance, therefore, udi is not applicable and was not included in the mdr.
Additional Manufacturer Narrative
To resolve the issue, the technician opened the water supply valves.The unit was tested, confirmed to be operating according to specification, and returned to service.While onsite the technician counseled user facility personnel on the proper use and operation of the amsco 400 sterilizer, specifically on reopening the valves of the sterilizer.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: 24021057
• Report Number: 3005899764-2026-00002
• Device Sequence Number: 21130087
• Product Code: FLE
• UDI-Device Identifier: 00724995209421
• UDI-Public: (01)00724995209421(11)210625
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2026

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: AMSCO 400 STEAM STERILIZER
• Device Catalogue Number: SR0201110111
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/23/2026; 03/09/2026; 04/29/2026
• Date Device Manufactured: 06/25/2021
• 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