MAUDE Adverse Event Report: STERIS MEXICO, S. de R.L. de C.V. AMSCO; 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	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their amsco 400 sterilizer was leaking water and emitting a ¿burning odor¿.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the amsco 400 sterilizer and found a generator control contactor stuck closed.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.To resolve the issue, the technician replaced the contactor and necessary components.After the unit was tested and confirmed operating according to specifications it was returned to service.A 2-year complaint review confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: Sterilizer
• Manufacturer (Section D): STERIS MEXICO, S. de R.L. de C.V.; avenida avante 790; parque industrial guadalupe; guadalupe nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. de R.L. de C.V.; avenida avante 790; parque industrial guadalupe; guadalupe nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50882026
• Report Number: 3005899764-2026-00074
• Device Sequence Number: 9826071
• Product Code: FLE
• UDI-Device Identifier: 00724995209421
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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

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: 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: 08/25/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2021
• 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