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

Model Number	AX082020003
Medical Device Problem Code	Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the cart required adjustment.This caused the cart to not lock in place correctly, subsequently causing the reported event.While onsite, the technician counseled user facility personnel on the proper maintenance of the evolution transfer cartilage.The technician ordered replacement parts to perform the necessary repairs.The cart has been removed from service pending repairs.A follow-up report will be submitted once the repairs are completed.
Event or Problem Description
The user facility reported that an employee obtained a bruise on their hand after a loading rack fell from their evolution transfer carriage.The employee sought medical treatment and received a bandage.
Additional Manufacturer Narrative
To resolve the issue, the technician replaced the front leg caster assembly of the transfer cart.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: EVOLUTION 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: 21048761
• Report Number: 3005899764-2024-00079
• Device Sequence Number: 14305175
• Product Code: FLE
• UDI-Device Identifier: 00724995150358
• UDI-Public: (01)00724995150358(11)180412
• 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
• Report Date (Section B): 12/31/2024

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
• Device Model Number: AX082020003
• Device Catalogue Number: AX082020003
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2018
• 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