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	Ecchymosis (1818)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that while an employee was using their evolution transfer carriage, the carriage became unstable and fell to the floor.The employee was reportedly bruised and sore.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the transfer cart and found that would not consistently latch in the latching station at the bottom of the sterilizer.After further inspection, the technician found that the latching mechanism was out of adjustment, causing intermittent latching.To resolve the issue, the technician adjusted the latching mechanism.After the unit was tested and confirmed operating according to specifications it was returned to service.This unit is not under steris contract agreement for maintenance services.The user facility is responsible for all maintenance activities.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 nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. de R.L. de C.V.; avenida avante 790; parque industrial guadalupe; guadalupe nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50713949
• Report Number: 3005899764-2026-00067
• Device Sequence Number: 18656064
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: (01)00724995150389
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/10/2026

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: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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