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

Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their 66" evolution transfer carriage fell to the ground during unloading from a sterilizer.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect 66" evolution transfer carriage and found that the unit's front rail system was bent.The 66" evolution transfer carriage is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The unit was removed from service and is currently pending repair.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The steris service technician further inspected the 66" evolution transfer carriage and found that the locking mechanism was severely damaged.Due to the damage that the transfer carriage had sustained, the technician removed the device from service.The steris service technician provided a quote to user facility personnel for the purchase of a new unit.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: 18159616
• Report Number: 3005899764-2023-00065
• Device Sequence Number: 8045274
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: 00724995150389
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/17/2023

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
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• 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