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

Model Number	AMSCO 400 STEAM STERILIZER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer is conducting an investigation as a follow-up to "inflammation" that occurred to a patient post procedure.The user facility did not disclose the current patient status or if any medical treatment was administered.We understand the user facility 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 400 sterilizer as a contributor to the reported event.The user facility did not disclose the specific instruments that were used during the procedure subject of the reported event.Steris is working to conduct inspection of the amsco 400 sterilizer.A follow-up report will be submitted once the inspection is complete.
Event or Problem Description
The user facility contacted steris requesting functional testing of their amsco 400 sterilizer.
Additional Manufacturer Narrative
A steris service technician inspected the sterilizer and found no issues with the function or operation of the unit.The technician checked all cycle parameters, ran dart and leak test cycles and found temperature and water pressure to all be within specification.The technician returned the sterilizer to service and no additional issues have been reported.

• Brand Name: AMSCO 400 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: 16204459
• Report Number: 3005899764-2023-00002
• Device Sequence Number: 4152193
• Product Code: FLE
• UDI-Device Identifier: 00724995210991
• UDI-Public: 00724995210991
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/19/2023

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 400 STEAM STERILIZER
• Device Catalogue Number: SR3201110111
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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