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

Model Number	AX083020003
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found no issues with the function or operation of the evolution transfer carriage; the transfer carriage was returned to service.However, the rack sustained damage as a result of the reported event.Based on the description of the event, it is likely that the transfer carriage's wheel assembly had not been properly locked to the sterilizer's docking station resulting in the reported event.To resolve the issue, the rack was removed from service, and the user facility elected not to replace the rack.A steris account manager performed in-service training on the proper use and operation of the evolution transfer carriage, specifically on properly latching the carriage to the docking station.No additional issues have been reported.
Event or Problem Description
The user facility reported that while an employee was unloading their sterilizer, their evolution transfer carriage became unstable and fell, damaging the instrument rack.No report of injury.

• Brand Name: NA
• Common Device Name: EVOLUTION TRANSFER CARRIAGE
• 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: 25173150
• Report Number: 3005899764-2026-00036
• Device Sequence Number: 16002329
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: (01)00724995150389(11)241114
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 05/14/2026

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: AX083020003
• Device Catalogue Number: AX083020003
• 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: 04/14/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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