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

Model Number	AMSCO 600 STEAM STERILIZER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the amsco 600 sterilizer and found the unit to be operating properly.No issues were noted with the function or operation and the reported event was unable to be duplicated.The technician stated that user facility personnel were utilizing sterilization trays that were weighing 37 pounds.The maximum weight of the trays should be 25 pounds.If the tray is too heavy, the sterilizer will have difficulty pulling the moisture out of the chamber during a processing cycle.The operator manual (pg.5) has a recommended load (maximum) of 25 pounds for instrument trays for specific cycle types, sterilization temperatures, sterilize time and dry time.The technician also observed that the steam filter assembly connected to the sterilizer required service.The steam filter assembly is not a steris device and is serviced and maintained by the user facility.The user facility is responsible for the service and maintenance of the steam filter assembly.The technician stated that if the steam filters are clogged or the steam trap is not functioning properly, water can build up and get pulled into the sterilizer's chamber.The steris service technician discussed the reported event with user facility personnel and counseled them on the proper use and operation of the amsco 600 sterilizer, specifically utilizing the tray weight and service needed for the steam filter assembly.The steris service technician returned the amsco 600 sterilizer to service and no additional issues have been reported.
Event or Problem Description
The user facility reported that water was remaining in the instrument trays after being processed in their amsco 600 sterilizer.Procedure delays and a procedure cancellation were reported.No report of injury.

• Brand Name: AMSCO 600 STERILIZER
• Common Device Name: AMSCO 600 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: 18183403
• Report Number: 3005899764-2023-00067
• Device Sequence Number: 7717080
• Product Code: FLE
• UDI-Device Identifier: 00724995179274
• UDI-Public: (01)00724995179274(11)211004(21)032772101
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/21/2023

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 600 STEAM STERILIZER
• Device Catalogue Number: EF1201110
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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