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

Model Number	AX083020003
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained a scratch on their hand after their evolution transfer carriage fell.The employee did not seek medical treatment and continued working.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the evolution transfer carriage and found that the two front wheels of the transfer cart released before the rack was fully removed from the sterilizer.After further inspection, the technician found that the front leg locking mechanism was out of adjustment.To resolve the issue, the technician adjusted the front leg locking mechanism to ensure proper engagement and safe operation of the transfer cart.The unit was tested, confirmed to be operating according to specification, and returned to service.The transfer carriage is not under a steris service contract for maintenance activities; the user facility is responsible for all maintenance activities.User facility personnel were counseled on the proper use and operation of the evolution transfer carriage as well as the proper preventive maintenance of the unit.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: 24688746
• Report Number: 3005899764-2026-00026
• Device Sequence Number: 9770558
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: (01)00724995150389(11)250828
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: 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: 02/26/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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