MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

Model Number	AMSCO 400 Steam Sterilizer
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the amsco 400 sterilizer and found that the heat exchanger required replacement.The technician stated that water was leaking into the heat exchanger which was creating steam.Steam was then drawn into the sterilizer's chamber through the chamber drain.The steris service technician replaced the heat exchanger, tested the sterilizer, and confirmed the unit to be operating to specification.The amsco 400 sterilizer was returned to service and no additional issues have been reported.
Event or Problem Description
The user facility reported that an employee's arm was contacted by steam when the chamber door was opened to their amsco 400 sterilizer.The employee sought and received medical treatment (ointment).

• Brand Name: AMSCO 400 STERILIZER
• 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: 17362624
• Report Number: 3005899764-2023-00036
• Device Sequence Number: 5289877
• Product Code: FLE
• UDI-Device Identifier: 00724995210564
• UDI-Public: 00724995210564
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/20/2023

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: 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: 06/23/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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