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	Failure to Align (2522)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported an employee obtained a burn to their face while retrieving a rack "stuck" in their amsco 400 steam sterilizer.The employee sought medical treatment; however, it is unknown if medical treatment was administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 400 steam sterilizer and found the chamber track was misaligned.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service.It was learned the employee subject of the reported event reached into the sterilizer to re-align the rack during unloading; attributing to the report of injury.The amsco 400 steam sterilizer operator manual states, "burn hazard: sterilizer, rack/shelves, and loading car will be hot after cycle is run.Always wear protective gloves and apron when removing a processed load.Protective gloves and apron must be worn when reloading sterilizer following the previous operation.Steam may be released from the chamber when the door is opened.Step back from the sterilizer each time the door is opened to minimize contact with steam vapor." multiple attempts have been made to contact the user facility to obtain additional information regarding the reported event; however, no response has been received.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
• MDR Report Key: 22036157
• Report Number: 3005899764-2025-00040
• Device Sequence Number: 8260851
• Product Code: FLE
• UDI-Device Identifier: 00724995210564
• UDI-Public: (01)00724995210564(11)240704
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 05/16/2025

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: AMSCO 400 STEAM STERILIZER
• Device Catalogue Number: SR2321211011
• 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: 03/20/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• 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