MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; AMSCO 600 STEAM STERILIZER

Model Number	AMSCO 600 STEAM STERILIZER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that water was leaking from their amsco 600 sterilizer onto the floor.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the amsco 600 sterilizer.The technician found that the safety valve was not operating properly subsequently causing the reported event.The safety valve was returned to the supplier for evaluation and found that one of the internal components of the safety valve was misaligned.The cause of the misalignment could not be determined.The technician replaced the safety valve, tested the function and operation of the sterilizer and returned the device to service.A 3-year complaint review confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: AMSCO 600 STEAM 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: 21978318
• Report Number: 3005899764-2025-00037
• Device Sequence Number: 7104850
• Product Code: FLE
• UDI-Device Identifier: 00724995179427
• UDI-Public: (01)00724995179427(11)250117
• 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): 05/07/2025

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 600 STEAM STERILIZER
• Device Catalogue Number: EF1201242
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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