MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; AMSCO DRYING CABINET

Model Number	DRYING CABINET
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the amsco drying cabinet and identified that the channel inside the cabinet that holds the rack in place had edges with a rough surface.The technician smoothed out the rough edges.The unit was tested, confirmed to be operating according to specification, and returned to service.A three-year complaint review confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that three employees obtained cuts to their finger(s) when loading a rack into their amsco drying cabinet.The first employee self-applied durabond on two of their fingers and continued working.The second employee was reported to have fainted and hit their head.It is unknown whether medical treatment was sought or administered for the second employee.No information was provided pertaining to the third employee.

• Brand Name: AMSCO
• Common Device Name: AMSCO DRYING CABINET
• 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: 21162133
• Report Number: 9680353-2025-00001
• Device Sequence Number: 18056465
• Product Code: PUP
• UDI-Device Identifier: 00724995162610
• UDI-Public: (01)00724995162610
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/15/2025

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: DRYING CABINET
• Device Catalogue Number: DCR100101
• 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: 12/18/2024
• Initial Report FDA Received Date: 01/15/2025
• 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