MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. ATLAS; 20" ATLAS TRANSFER CARRIAGE

Model Number	FV020002
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee injured their finger while unloading their 20" atlas transfer carriage from their sterilizer.The employee went to the emergency room; however, it is unknown if any medical treatment was received.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the atlas transfer carriage.During the technician's inspection he found that screws were missing on the front latch that lock into the sterilizer's chamber.As the front latch did not operate properly, this caused the transfer carraige to become unstable subsequently causing the reported event to occur.The technician repaired the transfer carriage, tested the function and operation of the device and returned it to service.No additional issues have been reported.The transfer carriage is not under a steris service contract for maintenance activities; the user facility is responsible for all maintenance activities.

• Brand Name: ATLAS
• Common Device Name: 20" ATLAS 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: 21326667
• Report Number: 3005899764-2025-00010
• Device Sequence Number: 20987777
• Product Code: FLE
• UDI-Device Identifier: 00724995150532
• UDI-Public: (01)00724995150532(11)170330
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K212424
• 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): 02/06/2025

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: FV020002
• Device Catalogue Number: FV020002
• 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: 01/07/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2017
• 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