MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; WASHER/DISINFECTOR

Model Number	1215
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that while an employee was loading a cart into their amsco 1215 cart and utensil washer/disinfector, the top panel of the unit detached and contacted her head and face.The employee sought and received medical treatment.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and found that the top panel screws were loose.The technician reinstalled the top panel and confirmed all screws were properly tightened.The technician tested the function and operation of the unit, confirmed it to be operating to specification, and returned the washer/disinfector to service.The amsco 1215 cart and utensil washer/disinfector is not under steris service agreement for preventive maintenance activities.The user facility is responsible for all maintenance activities.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: WASHER/DISINFECTOR
• 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: 24532905
• Report Number: 9680353-2026-00009
• Device Sequence Number: 13018352
• Product Code: MEC
• UDI-Device Identifier: 00724995214401
• UDI-Public: (01)00724995214401(11)240702
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 03/06/2026

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: 1215
• Device Catalogue Number: FW12102
• 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: 02/04/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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