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	Insufficient Information (4580)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the evolution transfer carriage and found the locking mechanism to be damaged.Because of the damage, the locking mechanism was able to become disengaged when force was applied to the carriage 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.Based on the technician's inspection and the damage to the locking mechanism, the reported event is likely attributed to user error as the transfer carriage may have had sustained impact damage and subsequently not repaired.The technician counseled user facility personnel on the proper use and operation of the evolution transfer carriage.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 while an employee was operating their evolution transfer carriage, it became unstable and fell to the floor resulting in an injury.
Additional Manufacturer Narrative
In lieu of repairing the evolution transfer carriage, the user facility has elected to discontinue use of the evolution sterilizer and evolution transfer carriage.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 ; 4403927453
• MDR Report Key: 16385001
• Report Number: 3005899764-2023-00007
• Device Sequence Number: 5618155
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: 00724995150389
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/16/2023

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: 01/20/2023
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2018
• 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