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

Model Number	AX0660230830000013
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite and found the front latches on the transfer carriage to be bent.The technician stated that the front latches were bent due to user facility personnel not properly aligning the transfer carriage in the sterilizer.As the front latches were bent, the transfer carriage was unable to properly engage to the sterilizer subsequently causing the reported event to occur.Steris discussed the reported event with user facility personnel and the importance of properly aligning the transfer carriage within the sterilizer.The transfer carriage is not under a steris service contract and is serviced and maintained by the user facility.The transfer carriage has been removed from service and is pending repairs.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their atlas transfer carriage did not stay engaged within the sterilizer and subsequently contacted an employee.The employee obtained a burn and applied a band-aid.
Additional Manufacturer Narrative
In lieu of repairs, the user facility has purchased a new transfer carriage.No additional issues have been reported.

• Brand Name: ATLAS TRANSFER CARRIAGE
• 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 ; 4403927453
• MDR Report Key: 15943369
• Report Number: 3005899764-2022-00060
• Device Sequence Number: 6219812
• Product Code: FLE
• UDI-Device Identifier: 00724995150631
• UDI-Public: 00724995150631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/08/2022

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: 11/10/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• 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