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

Model Number	HC-1500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event.The technician inspected the evolution sterilizer and found the vacuum pump overload relay had tripped at the end of the dart cycle, causing steam to remain inside the chamber.The technician made repairs and adjustments to the unit, tested the function and operation, and returned the unit to service.A 3-year complaint review confirmed the event to be isolated.No additional issues have been reported.
Event or Problem Description
The user facility reported that following a dart test cycle an employee opened the door to their amsco evolution sterilizer and obtained a burn.It is unknown if medical treatment was sought or administered.

• Brand Name: AMSCO EVOLUTION
• Common Device Name: AMSCO EVOLUTION 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: 22643188
• Report Number: 3005899764-2025-00065
• Device Sequence Number: 8798138
• Product Code: FLE
• UDI-Device Identifier: 00724995151522
• UDI-Public: (01)00724995151522(11)240912
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/29/2025

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: HC-1500
• Device Catalogue Number: UE06
• 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: 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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