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

Model Number	AMSCO 600 STEAM STERILIZER
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported a small amount of smoke emitted from their amsco 600 sterilizer.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found the contactor for the steam generator was damaged.The damage observed is indicative of the contactor overheating which likely resulted in the reported smoke.A cause of the issue with the contactor could not be determined.As designed, the unit's high limit pressure switch was activated at the time of the event to shut off the heater contactor.The asmco 600 steam sterilizer is designed with flame-resistant materials and is certified by intertek to ul 61010-1:2012 3rd ed./csa c22.2#61010-1-12:2012, 3rd ed.Safety requirements for electrical equipment for measurement, control and laboratory use, part 1, and ul 61010-2-040:2021, 3rd ed/csa c22.2#61010-2-040:2021 3rd ed., safety requirements, part 2-040 - particular requirements for sterilizers and washer-disinfectors to treat medical materials.The technician replaced the contactor, tested the unit, confirmed it to be operating according to specification, and returned it to service.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, 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: 24942082
• Report Number: 3005899764-2026-00030
• Device Sequence Number: 12998559
• Product Code: FLE
• UDI-Device Identifier: 00724995179236
• UDI-Public: (01)00724995179236(11)231222
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/21/2026

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: AMSCO 600 STEAM STERILIZER
• Device Catalogue Number: EF1101142
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2023
• 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