MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; AMSCO 7052HP WASHER-DISINFECTOR

Model Number	7052HP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the washer subject of the reported event.The steris technician inspected the washer and found it to be operating per specifications.No repairs were required, and the unit was returned to service.The reported event is attributed to the employee manually pushing the rack further into the washer after the rack became jammed.The amsco 7052 hp washer/disinfector operator manual states (section 4.13.1), "if an obstruction is present at the bottom of the wash chamber door, do not attempt to remove the object.A door safety sensor on the door button detects the obstruction.Door automatically stops from closing and opens completely." the operator manual further states, "if an obstruction is present in the chamber door, do not attempt to remove the object." the technician counseled user facility personnel on proper loading techniques and safety operation protocols.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained wrist injury after removing an obstruction from the doorway of their amsco 7052 hp washer/disinfector.The employee sought treatment and received x-rays.

• Brand Name: AMSCO
• Common Device Name: AMSCO 7052HP 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: 23849396
• Report Number: 9680353-2025-00052
• Device Sequence Number: 15960032
• Product Code: MEC
• UDI-Device Identifier: 00724995176570
• UDI-Public: (01)00724995176570(11)210209
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/19/2025

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: FH18072
• 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: 11/24/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• 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