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

Model Number	AX083020003
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and learned while user facility personnel were turning the evolution transfer carriage the front leg assembly slid towards the handle, subsequently causing the reported event.The technician inspected the carriage and found the front leg assembly required adjustments due to a lack of preventive maintenance by user facility personnel.The unit is not under steris service agreement for preventive maintenance activities; the user facility is responsible for all maintenance activities.The evolution transfer carriage operator manual states, "a thorough preventive maintenance program is essential to safe and proper unit operation.This manual contains maintenance schedules and procedures which should be followed for satisfactory equipment performance." to resolve the issue, the technician will replace the front leg assembly and provide counseling to user facility personnel on the proper preventive maintenance of the evolution transfer carriage.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported their evolution transfer carriage "fell down" while transporting a load.No report of injury.
Additional Manufacturer Narrative
The technician replaced the front leg assembly to the evolution transfer carriage.The carriage was tested, confirmed to be operating according to specification, and returned to service.While onsite, the technician counseled user facility personnel on the proper preventive maintenance practices for the evolution transfer carriage.No additional issues have been reported.

• 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: 22974397
• Report Number: 3005899764-2025-00073
• Device Sequence Number: 8937752
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: (01)00724995150389(11)201201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/04/2025

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: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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