MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. ATLAS; ATLAS LOADING CAR

Model Number	AX015013081
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the loading car and transfer carriage.The technician found no issues with the function or operation of the loading car and transfer carriage and confirmed them to be operating to specifications.During follow-up with user facility personnel, it was confirmed that the employee did not properly latch the loading car to the transfer carriage subsequently causing the loading car to become unstable during unloading, leading to the reported event.The technician performed in-service training on the proper use and operation of the loading car specifically, the importance of ensuring the loading car is properly latched to the transfer carriage.The operator manual states (pg.3-1), "always positively latch loading car to transfer carriage when car is outside sterilizer." the technician returned the loading car and transfer carriage to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported an employee injured their shoulder while attempting to lift the loading car to their atlas transfer carriage.The employee went to the facility's emergency room; however, it is unknown what treatment may have been administered.

• Brand Name: ATLAS
• Common Device Name: ATLAS LOADING CAR
• 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 ; 4402597401
• MDR Report Key: 23672051
• Report Number: 3005899764-2025-00095
• Device Sequence Number: 9761437
• Product Code: FLE
• UDI-Device Identifier: 00724995150792
• UDI-Public: (01)00724995150792(11)220114
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 11/28/2025

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: AX015013081
• Device Catalogue Number: AX015013081
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• 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