MAUDE Adverse Event Report: STERIS MEXICO, S. de R.L. de C.V. AMSCO 600 Sterilizer

Model Number	AX000B6
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a cycle their amsco 600 sterilizer alarmed for ¿over temperature¿.Following the alarm, water leaked from the unit onto the floor.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the amsco 600 sterilizer and found the sterilizer powered off.The technician reviewed the alarm history which identified the unit had experienced ¿too long to evacuate¿, ¿too long to seal door¿ and ¿door unsealed¿.The technician restored power to the sterilizer and observed the reported event cycle to be active, resulting in the release of water from the chamber.During the technician¿s inspection he found that the generator float required replacement.As the generator float within the steam generator remained energized, this allowed water to continuously enter the system through valves v2 and v9 while the sterilizer was being pressurized.This led to the accumulation of water in the steam generator, jacket, and chamber.The technician removed the unit from service and is awaiting replacement components.A follow-up report will be submitted when the device is returned to service.

• Brand Name: AMSCO 600 Sterilizer
• 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: 50817829
• Report Number: 3005899764-2026-00071
• Device Sequence Number: 10152133
• Product Code: FLE
• UDI-Device Identifier: 00724995203016
• UDI-Public: (01)00724995203016(11)211228
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K232485
• 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): 09/18/2026

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: AX000B6
• Device Catalogue Number: AX000B6
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• 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