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

Model Number	7052HP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported an employee "slipped but did not fall" on lubricant leaking from their amsco 7052hp washer/disinfector.The leak was quickly contained and the employee continued working.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 7052hp washer/disinfector and found the check valve that supplies lubricant to the unit was damaged resulting in the reported event.To resolve the issue, the technician replaced the check valve.The technician tested the function and operation of the unit, confirmed it to be operating to specification, and returned it to service.The check valve subject of the reported event was discarded by the user facility and is not available for evaluation.The amsco 7052hp washer/disinfector subject of the reported event is not under steris service agreement for preventive maintenance.The user facility is responsible for all maintenance activities.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: 24402863
• Report Number: 9680353-2026-00005
• Device Sequence Number: 18182331
• Product Code: MEC
• UDI-Device Identifier: 00724995176587
• UDI-Public: (01)00724995176587(11)210608
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7052HP
• Device Catalogue Number: FH18042
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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