MAUDE Adverse Event Report: CORPORATION STERIS CANADA; CONTAINER RACK

Model Number	FD322
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained an injury when the wheel assembly of the container rack to their vision 1327 cart washer/disinfector detached, causing the container rack to tip and strike the employee's shoulder.The employee sought medical treatment and received medication, physical therapy, and returned to work.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the container rack and found that the jam nuts were loose on the wheel assemblies of two container racks.To resolve the issue, the technician re-secured the wheel assemblies.The unit was tested, confirmed to be operating according to specification, and returned to service.The container rack is not under a steris service contract for maintenance activities; the user facility is responsible for all maintenance activities.Steris provided in-service training on the proper use and operation of the container rack, specifically on proper maintenance practices.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: CONTAINER RACK
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25311074
• Report Number: 9680353-2026-00026
• Device Sequence Number: 12136487
• Product Code: MEC
• UDI-Device Identifier: 00724995151089
• UDI-Public: (01)00724995151089
• 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
• Report Date (Section B): 05/27/2026

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: FD322
• Device Catalogue Number: FD322
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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