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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer is conducting an investigation as a follow-up to three infections that occurred in three separate patients post procedure.The infections occurred following procedures with the same surgeon.The user facility did not disclose the current patient status or if any medical treatment was administered.We understand the hospital is reviewing all their pre- and post-procedural standard operating procedures.The customer contacted steris asking we perform an evaluation of their equipment in an attempt to rule out the amsco 600 sterilizers as the root cause of the reported infections.The user facility did not disclose the specific instruments that were used on the patients that obtained infections.The user facility reported that biological indicators were present and evidenced passing results.Biological indicators are utilized with every load.A steris service technician arrived onsite to inspect the sterilizers.The technician ran test cycles which completed successfully and confirmed the amsco 600 sterilizers to be operating according to specification.The technician proactively descaled the steam generators and returned the units to service.The technician also inspected the chambers and rack assemblies and found no issues.Our investigation concluded that our amsco 600 sterilizers are operating according to specification.A steris clinical education specialist provided a refresher in-service training to the customer on proper pre-cleaning, processing, and inspection of devices.No additional issues have been reported.
Event or Problem Description
The user facility contacted steris requesting functional testing of their three amsco 600 sterilizers.

• Brand Name: AMSCO 600 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 ; 4403927453
• MDR Report Key: 12637423
• Report Number: 3005899764-2021-00053
• Device Sequence Number: 19182914
• Product Code: FLE
• UDI-Device Identifier: 00724995179434
• UDI-Public: 00724995179434
• 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): 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AMSCO 600 Steam Sterilizer
• Device Catalogue Number: EF1201142
• 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: 09/16/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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