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

Model Number	HC-1500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the sterilizer and found that the bolts that secure the upper panel into place were already replaced by the user facility.The technician tested the sterilizer, confirmed it to be operating to specifications and, returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that the upper panel of their amsco evolution sterilizer detached and contacted the employee.The user facility did not disclose further details regarding the injury or if medical treatment was sought or administered.

• Brand Name: AMSCO EVOLUTION
• Common Device Name: AMSCO EVOLUTION 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 ; 4402597401
• MDR Report Key: 24446872
• Report Number: 3005899764-2026-00015
• Device Sequence Number: 16029092
• Product Code: FLE
• UDI-Device Identifier: 00724995151522
• UDI-Public: (01)00724995151522(11)210420
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: HC-1500
• Device Catalogue Number: UE06
• 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: 01/26/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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