MAUDE Adverse Event Report: CORPORATION STERIS CANADA; RACK

Model Number	FD107
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that one of the blue handles was missing from the side of the rack.The root cause of the missing handles is likely attributed to improper maintenance by user facility personnel.Additionally, it was discovered that the employee subject of the reported event was not wearing the proper ppe, specifically gloves, while handling the three level manifold rack.The three level manifold rack states, "rack and items are extremely hot when cycle is completed.Allow rack and items to cool to room temperature and always wear appropriate ppe before reaching into the chamber." new handles for the three level manifold rack were ordered and the rack is currently pending repairs.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that an employee obtained a burn on their hand while trying to unload a three level manifold rack from their washer.The employee did not seek medical treatment and returned to work.
Additional Manufacturer Narrative
To resolve the issue, the technician replaced the handles of the three level manifold rack.The unit was tested, confirmed to be operating according to specifications, and returned to service.The technician counseled user facility personnel on wearing proper ppe, specifically gloves, while using the rack.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: 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
• MDR Report Key: 21004270
• Report Number: 9680353-2024-00045
• Device Sequence Number: 18608607
• Product Code: MEC
• UDI-Device Identifier: 00724995150969
• UDI-Public: (01)00724995150969(11)220129
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 12/23/2024

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
• Device Model Number: FD107
• Device Catalogue Number: FD107
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 05/08/2025; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2022
• 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