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

Model Number	HC-1200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their amsco evolution sterilizer was leaking water and steam onto the floor.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the sterilizer and found that the contactor on the heater of the generator was stuck in the closed position.As the contactor was stuck in the closed position, this allowed continuous power to be provided to the unit causing excess steam to build up.As designed, the safety valve opened, and excess steam emitted from the unit.The technician made the necessary repairs.The unit was tested, confirmed to be operating according to specifications, and it was returned to service.A 1-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: AMSCO EVOLUTION
• 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
• MDR Report Key: 22458129
• Report Number: 3005899764-2025-00056
• Device Sequence Number: 8156200
• Product Code: FLE
• UDI-Device Identifier: 00724995151508
• UDI-Public: (01)00724995151508(11)190920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/09/2025

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: HC-1200
• Device Catalogue Number: UE05
• 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: 06/09/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2019
• 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