MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V.; ATLAS 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	11/18/2025
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 the docking station, transfer carriage and the loading car were damaged as a result of the reported event.Based on the description of the event and the technician's inspection, it is likely that the transfer carriage's front wheel assembly had not been properly locked to the sterilizer's docking station resulting in the reported event.The carriage subject of the reported event is pending repairs.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that their evolution transfer carriage fell to the floor while an employee was unloading the sterilizer.No report of injury.
Additional Manufacturer Narrative
To resolve the issue, the technician replaced the cart and repaired the docking station.The unit was tested, confirmed to be operating according to specification, and returned to service.A steris account manager provided 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.

• Brand Name: NA
• Common Device Name: ATLAS 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: 23843486
• Report Number: 3005899764-2025-00100
• Device Sequence Number: 13251405
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: (01)00724995150389(11)241108
• 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): 12/18/2025

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: 11/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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