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

Model Number	AMSCO 400 Steam Sterilizer
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction

• 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 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: 50144944
• Report Number: 3005899764-2026-00053
• Device Sequence Number: 18421887
• Product Code: FLE
• UDI-Device Identifier: 00724995209414
• UDI-Public: (01)00724995209414(11)150521
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K111223
• 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): 08/05/2026

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 400 Steam Sterilizer
• Device Catalogue Number: SR0201110011
• 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: 07/07/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2015
• 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