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

Model Number	AX082020003
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Ecchymosis (1818)
Date of Event	08/05/2021
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 loading their sterilizer resulting in a bruise on their arm.Medical treatment was sought and administered.(ibuprofen).
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the evolution transfer carriage and found that the locking pins were unable to align with the sterilizer's docking station.This allowed the wheels to become unlocked resulting in the reported event.The root cause of the reported event is impact damage by facility personnel subsequently allowing the locking pins to become misaligned.The evolution transfer carriage is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The unit has been removed from service pending repairs.The technician counseled facility personnel on the proper use and operation of the transfer carriage, specifically the importance of not bumping the transfer carriage into walls or other equipment.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The technician replaced the wheel carriage assembly.Tested the unit, confirmed, it to be operating according to specifications.And returned it 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 ; 4403927453
• MDR Report Key: 12414104
• Report Number: 3005899764-2021-00048
• Device Sequence Number: 3515958
• Product Code: FLE
• UDI-Device Identifier: 00724995150358
• UDI-Public: 00724995150358
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 09/02/2021

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: AX082020003
• Device Catalogue Number: AX082020003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 08/05/2021; 08/05/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/27/2021; 10/07/2021; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2018
• 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