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	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the 66" evolution transfer carriage and found that the locking mechanism was bent.As the locking mechanism was bent, this may have caused the transfer carriage to not properly engage with the docking station resulting in the reported event.This unit is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The technician counseled user facility personnel on the proper use and operation of the evolution transfer carriage, including proper maintenance activities.The carriage has been removed from service and is pending repairs.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their 66" evolution transfer carriage fell to the floor while an employee was unloading the sterilizer.No report of injury.
Additional Manufacturer Narrative
The steris service technician replaced the locking mechanism, tested the function and operation of the transfer carriage, and returned the device to service.No additional issues have been reported.

• Brand Name: EVOLUTION TRANSFER CARRIAGE
• Common Device Name: 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
• MDR Report Key: 18291456
• Report Number: 3005899764-2023-00068
• Device Sequence Number: 6667610
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: (01)00724995150389(11)200416
• 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,Followup
• Report Date (Section B): 12/08/2023

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: 11/10/2023
• Supplement Date Received by Manufacturer: 11/10/2023; Not provided
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/17/2024; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2020
• 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