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	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained an injury to their back while loading their atlas transfer carriage into a amsco 400 steam sterilizer.The user facility did not disclose information regarding the reported injury however, no medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite and observed that user facility personnel were utilizing multiple transfer carriages with their sterilizer.Due to height differences of the transfer carriages and the unevenness of the facility's flooring, this caused the transfer carriages to not line up to the sterilizer's docking station properly subsequently causing damage to the transfer carriage's front casters.As the transfer carriage's front casters were damaged, the casters could not engage to the sterilizer's docking station properly.The steris technician removed the transfer carriage from service and is pending repairs.A follow-up report will be submitted once repairs are completed for the transfer carriage.
Additional Manufacturer Narrative
The steris service technician tightened the casters, confirmed the atlas transfer carriage to be operating properly, and returned the unit to service.User facility personnel were counseled on the importance of only using designated carriages with their corresponding sterilizers to ensure proper alignment and prevent reoccurrence of the reported event.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
• MDR Report Key: 20043030
• Report Number: 3005899764-2024-00042
• Device Sequence Number: 7977146
• Product Code: FLE
• UDI-Device Identifier: 00724995150600
• UDI-Public: (01)00724995150600(11)230920
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 08/22/2024

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: 07/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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