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

Model Number	AX082020003
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee was moving their 54" transfer carriage across the room and the front of the transfer carriage fell to the ground.The employee utilizing the transfer carriage stated their wrists after attempting to keep the transfer carriage from falling however, no medical treatment was sought or administered.No procedure delays were reported.
Additional Manufacturer Narrative
Instruments present on the transfer carriage were reprocessed prior to use.Steris service technician arrived onsite and found the locks on the front wheels of the transfer carriage were not operating properly.As the locks were not operating properly this caused the transfer carriage to fall forward.The carriage was removed from service and is pending repairs.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
The steris service technician stated that the user facility declined to have their 54" transfer carriage repaired.The user facility is scheduled to receive a new transfer carriage.No additional issues have been reported.

• Brand Name: EVOLUTION 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: 14569435
• Report Number: 3005899764-2022-00023
• Device Sequence Number: 12036109
• Product Code: FLE
• UDI-Device Identifier: 00724995150358
• UDI-Public: 00724995150358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/01/2022

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: AX082020003
• Device Catalogue Number: AX082020003
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2018
• 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