MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. N/A; LOADING CAR

Model Number	AX082010001
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the evolution loading cars (serial numbers (b)(6).The technician identified "sharp" edges on the loading cars' shelf.The loading cars of the reported event have been removed from service and awaiting replacements.A follow-up mdr will be submitted once new information becomes available.No additional issues have been reported.
Event or Problem Description
The user facility reported that their evolution loading cars had sharp edges which are snagging and tearing holes in their surgical packs.A procedure delay was reported as user facility personnel elected to reprocess instruments.No report of injury.
Additional Manufacturer Narrative
The user facility has received new shelves.No additional issues have been reported.

• Brand Name: N/A
• Common Device Name: LOADING CAR
• 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: 21074140
• Report Number: 3005899764-2025-00002
• Device Sequence Number: 8497805
• Product Code: FLE
• UDI-Device Identifier: 00724995150372
• UDI-Public: (01)00724995150372(11)230104
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AX082010001
• Device Catalogue Number: AX082010001
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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