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

Model Number	AMSCO 400 STEM STERILIZER
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the door of their amsco 400 sterilizer was "hanging off".No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the door had been reinstalled by user facility personnel.The user facility elected to make the repairs themselves.While onsite, the technician tested the function and operation of the unit, and no issues were noted.The sterilizer was returned to service.An exact cause of the event could not be determined as the repairs to the unit were completed prior to the technician's inspection.No additional issues have been reported.
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that the doors to two of their amsco 400 sterilizers are "hanging off".No report of injury.

• Brand Name: AMSCO
• Common Device Name: AMSCO 400 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: 22612532
• Report Number: 3005899764-2025-00064
• Device Sequence Number: 9737587
• Product Code: FLE
• UDI-Device Identifier: 00724995210212
• UDI-Public: (01)00724995210212(11)230927
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 STEM STERILIZER
• Device Catalogue Number: SR2222213011
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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