MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; AMSCO 400 STEAM STERILIZER

Model Number	AMSCO 400 STEAM STERILIZER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found no issues with the function or operation.The unit was confirmed to be operating to specifications, and the reported event could not be duplicated.The operator manual states (pg.45), "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 technician proactively rebuilt the s2 valve, tested the unit and confirmed it to be operating properly.The amsco 400 sterilizer was returned to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that an employee received a steam "burn" to the back of their hand while opening their amsco 400 sterilizer door and reaching for the cycle printout tape.No medical treatment was sought or administered and the employee continued working.

• Brand Name: AMSCO
• Common Device Name: AMSCO 400 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: 23544742
• Report Number: 3005899764-2025-00088
• Device Sequence Number: 9327415
• Product Code: FLE
• UDI-Device Identifier: 00724995209254
• UDI-Public: (01)00724995209254(11)190205
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/13/2025

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: SR0101110311
• 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: 10/15/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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