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

Model Number	HC-2000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that a sterilizer cart had become jammed in the door.When user facility personnel attempted to push the sterilizer cart into the unit, the door contacted the employee's hand.The cause of the reported event was the improper loading of the medium evolution sterilizer cart.The technician tested the function and operation of the unit, confirmed it to be operating to specification, and returned it to service.No repairs were required.The technician counseled user facility personnel on the proper use and operation of the medium evolution sterilizer, specifically on the proper loading of the sterilizer.No additional issues have been reported.
Event or Problem Description
The user facility reported that while handling the cart inside of their medium evolution sterilizer, the door closed and contacted the employee's hand.Medical treatment was sought; however, it is unknown what medical treatment was administered.

• Brand Name: AMSCO EVOLUTION
• 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 ; 4402597401
• MDR Report Key: 25302569
• Report Number: 3005899764-2026-00039
• Device Sequence Number: 9249176
• Product Code: FLE
• UDI-Device Identifier: 00724995151553
• UDI-Public: (01)00724995151553(11)180213
• 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
• Report Date (Section B): 05/27/2026

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-2000
• Device Catalogue Number: UE41
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2018
• 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