MAUDE Adverse Event Report: STERIS MEXICO, S. de R.L. de C.V. AMSCO; Transfer Carriage

Model Number	20
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the front wheels to their evolution transfer carriage did not latch properly to the sterilizer¿s docking station subsequently causing the carriage to fall.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the transfer carriage manifold and found that the front wheels did not properly engage after the manifold was pulled out of the sterilizer, causing the manifold to fall to the floor.After further inspection, the technician found that the leg lock assembly and release mechanism were misaligned, preventing proper operation of the front wheel locking system.To resolve the issue, the technician adjusted and realigned the front assembly of the transfer carriage, including the leg lock assembly and release mechanism.After the equipment was tested and confirmed operating according to specifications, it was returned to service.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: Transfer Carriage
• Manufacturer (Section D): STERIS MEXICO, S. de R.L. de C.V.; avenida avante 790; parque industrial guadalupe; guadalupe nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. de R.L. de C.V.; avenida avante 790; parque industrial guadalupe; guadalupe nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50696781
• Report Number: 3005899764-2026-00066
• Device Sequence Number: 13182828
• Product Code: FLE
• UDI-Device Identifier: 00724995151652
• UDI-Public: (01)00724995151652(11)200504
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 20
• Device Catalogue Number: SR02
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2020
• 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