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

Model Number	AX0650230830000013
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an instrument rack unloaded at an angle on the cart of their atlas transfer carriage.The employee attempted to manually lift the rack and subsequently pinched their finger between the rack and carriage.Medical treatment was sought and administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and tested the operation and function of the unit.The technician found no issues with the unit and was unable to duplicate the reported event.The unit was confirmed to be operating properly and returned to service.The atlas transfer carriage operator manual states, "rails on transfer cart must be leveled front to rear, and aligned vertically and horizontally with tracks inside sterilizer.Failure to adjust transfer cart rails as presented in this manual may result in injury to personnel or damage to product and equipment." the operator manual also states, "warning - prevent phsyical injury: get help if loading car becomes stuck or difficult to move.Do not attempt to lift a loading car without assistance." the technician counseled user facility personnel on the proper use and operation of the atlas transfer carriage, specifically on not manually lifting the loading car without assistance.No additional issues have been reported.

• 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: 24530934
• Report Number: 3005899764-2026-00019
• Device Sequence Number: 13349928
• Product Code: FLE
• UDI-Device Identifier: 00724995150600
• UDI-Public: (01)00724995150600(11)200220
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 03/06/2026

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: AX0650230830000013
• Device Catalogue Number: AX0650230830000013
• 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: 02/05/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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