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

Model Number	AX0660230830000013
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the atlas transfer carriage and found that the transfer carriage rail was bent, causing the carriage to mis-align to the rail inside the sterilizer.Upon further investigation it was learned that the employee "pulled forcefully" on the atlas transfer carriage at the time of the reported event.To resolve the issue, the technician adjusted the rollers and washers on the transfer carriages, straightened the rail guides, and ensured the sterilizer docking points were level with transfer carriages.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.
Event or Problem Description
The user facility reported an employee obtained an injury to their shoulder while attempting to remove the atlas transfer carriage from the sterilizer.The employee sought medical treatment; however, it is unknown what medical treatment was administered.

• Brand Name: ATLAS
• 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 ; 4402597401
• MDR Report Key: 24845361
• Report Number: 3005899764-2026-00029
• Device Sequence Number: 17539366
• Product Code: FLE
• UDI-Device Identifier: 00724995150631
• UDI-Public: (01)00724995150631(11)201030
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: AX0660230830000013
• Device Catalogue Number: AX0660230830000013
• 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: 03/13/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• 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