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

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	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the transfer carriage and found the front leg lock assembly required adjustments.As the front leg lock assembly was not properly adjusted the transfer carriage was able to become unlocked resulting in the reported event.The front leg lock assembly may come out of adjustment over time if not properly inspected and maintained during regularly scheduled preventive maintenance.The evolution transfer carriage is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The technician adjusted the front leg lock assembly, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.
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.

• Brand Name: EVOLUTION TRANSFER CARRIAGE
• Common Device Name: STERILIZER
• 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: 12451493
• Report Number: 3005899764-2021-00049
• Device Sequence Number: 16445831
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: 00724995150389
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/09/2021

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: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2018
• 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