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

Model Number	AX0660230830000013
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found that the catch rod of the latching system was damaged due to improper maintenance by user facility personnel.To resolve the issue, the technician replaced the catch rod of the latching system.The unit was tested, confirmed to be operating according to specification, and returned to service.The unit is not under steris service agreement for preventive maintenance activities; the user facility is responsible for all maintenance activities.While onsite the technician counseled user facility personnel on the proper maintenance of the atlas transfer carriage.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained a burn on their arm after struggling to unlatch the atlas transfer carriage from their sterilizer.The employee received burn cream and a bandage and returned to work.

• Brand Name: ATLAS
• Common Device Name: TRANSFER CARIAGE
• 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: 23621683
• Report Number: 3005899764-2025-00090
• Device Sequence Number: 18386845
• Product Code: FLE
• UDI-Device Identifier: 00724995150631
• UDI-Public: (01)00724995150631(11)230509
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/21/2025

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: 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: 10/23/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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