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

Model Number	7052HP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found no issues with the function or operation of the device.The door is activated by a touch panel.The reported event may have been caused by inadvertent activation of the touch panel by user facility personnel.The technician tested the unit, confirmed it to be operating according to specifications, and returned it to service.The technician counseled user facility personnel on proper use and operation of the amsco 7052 hp washer/disinfector.No additional issues have been reported.
Event or Problem Description
The user facility reported that while removing instruments from an amsco 7052 hp washer/disinfector, the washer door contacted on an employee's forearm, resulting in a bruise.The door retracted after contacting the employee's forearm, and the safety bar functioned as designed.Medical treatment was sought; however, it is unknown what medical treatment was administered.

• 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: 24835638
• Report Number: 9680353-2026-00016
• Device Sequence Number: 18433916
• Product Code: MEC
• UDI-Device Identifier: 00724995176587
• UDI-Public: (01)00724995176587(11)230419
• 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): 04/09/2026

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: 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: 03/13/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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