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

Model Number	7053HP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee sustained a hand sprain while removing a rack from their amsco 7053 hp washer/disinfector.The employee sought medical treatment and was advised to apply ice.The employee has returned to work.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 7053hp washer/disinfector and found that the sliding inlet was detached from the water inlet located at the bottom of the unit's chamber.Further investigation revealed that the retainer screw which secures the sliding inlet was missing.To resolve the issue, the technician replaced the retainer screw and reinstalled the sliding inlet.The technician tested the function and operation of the unit, confirmed it to be operating to specification, and returned it to service.A 3-year complaint review indicates this to be an isolated event.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: 24570679
• Report Number: 9680353-2026-00011
• Device Sequence Number: 12850712
• Product Code: MEC
• UDI-Device Identifier: 00724995176662
• UDI-Public: (01)00724995176662(11)240613
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: 7053HP
• Device Catalogue Number: FH19042
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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