MAUDE Adverse Event Report: Corporation Steris Canada AMSCO 7053HP Washer-Disinfector; Washer/Disinfector

Model Number	7053HP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported while an employee was cleaning their amsco 7053hp washer/disinfector the panel that cover's the facility's plumbing/water inlet adjacent to the unit detached and "struck" the employee on the arm.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 7053hp washer/disinfector and confirmed the reported event.The technician was unable to determine a cause of the reported event.To resolve the issue the technician secured the panel and confirmed the positioning of the panel's latches.The technician confirmed the amsco 7053hp washer/disinfector to be operating according to specification and returned the unit to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: AMSCO 7053HP Washer-Disinfector
• 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 ; +1(440)259-7401
• MDR Report Key: 50082608
• Report Number: 9680353-2026-00032
• Device Sequence Number: 10760831
• Product Code: MEC
• UDI-Device Identifier: 00724995176679
• UDI-Public: (01)00724995176679(11)251009
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: FH19043
• 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: 06/30/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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