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	03/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their evolution transfer carriage fell to the floor while an employee was unloading their sterilizer.No report of injury.
Additional Manufacturer Narrative
All instruments subject of the reported event were reprocessed prior to use.A steris service technician arrived onsite to inspect the transfer carriage and found that it was damaged.Upon further inspection, the technician found that the transfer carriage's locking pins did not align with the sterilizer's docking station allowing the wheels to become unlocked resulting in the reported event.The transfer carriage subject of the reported event has been removed from service.The user facility was provided with a replacement 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: 14237903
• Report Number: 3005899764-2022-00017
• Device Sequence Number: 4421385
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: 00724995150389
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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: 03/29/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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