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

Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the evolution transfer carriage and found that the docking plate where the transfer carriage engages was damaged.It is unknown if this damage was present prior to the reported event or caused by the falling transfer carriage.Additionally, the technician found that the user facility had attached zip ties near the locking pin on the transfer carriage.The locking pin is intended to hold the front legs of the transfer carriage to the docking station while unloading the sterilizer.If the pin was not fully engaged due to the zip ties, then this may have resulted in the reported event.The unit is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The technician replaced the docking plate and removed the customer's zip ties from the transfer carriage.The unit was tested, confirmed to be operating according to specifications, and returned to service.The technician counseled user facility personnel on the proper use and operation of the evolution transfer carriage, including proper maintenance activities.No additional issues have been reported.
Event or Problem Description
The user facility reported that their evolution transfer carriage fell forward while an employee was unloading their sterilizer resulting in shoulder pain.The employee sought medical treatment and received an x-ray.The employee has returned to work.

• 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
• MDR Report Key: 18676806
• Report Number: 3005899764-2024-00006
• Device Sequence Number: 15288361
• Product Code: FLE
• UDI-Device Identifier: 00724995150389
• UDI-Public: 00724995150389
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/09/2024

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
• 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: 01/11/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2018
• 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