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	Pain (1994)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The loads present on the transfer carriage during the time of the reported event were reprocessed.A steris service technician arrived onsite and found the docking station on the sterilizer to be damaged.The damage on the docking station caused the transfer carriage to not lock properly subsequently causing the reported event to occur.The loading cart sustained damage when the transfer carriage made impact with the floor; the loading cart and transfer carriage were removed from service.The technician repaired the docking station, tested the sterilizer, and returned the unit to service.Through follow-up, the damage to the docking station may be attributed to user facility personnel pushing/pulling the transfer carriage from the sterilizer's docking station too hard subsequently causing misalignment to the docking station's locking pins.A steris account manager performed in-service training on the proper use and operation for the transfer carriage and the importance of properly engaging the transfer carriage to the sterilizer's docking station.
Event or Problem Description
The user facility reported that when an employee was removing the loading cart from inside the sterilizer, their 66" transfer carriage did not remain engaged in the docking station.The transfer carriage subsequently fell to the ground causing the operator to obtain an injury to their foot.No medical treatment was sought or administered.

• 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: 15198948
• Report Number: 3005899764-2022-00035
• Device Sequence Number: 15056244
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 07/13/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 08/29/2022
• 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