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

Model Number	7052HP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A steris service technician arrived onsite to investigate the reported event and noted no issues with the function or operation to the amsco 7052hp washer/disinfector.Upon further investigation the technician learned the door obstruction alarm was activated at the time of the reported event due to a tray sticking out of an instrument rack located in the wash chamber and that the employee removed the obstruction.After clearing the alarm condition, the employee continued loading instrument racks into the washer.While loading the racks, the employee failed to remove their hand from between two racks, resulting in their hand becoming pinched and causing the reported injury.The operator manual for the amsco 7052hp washer/disinfector provides the following warning to the user, "warning personal injury hazard when baskets are present on the conveyor modules, keep fingers and hands away from wash chamber doors and moving baskets." a steris account manager performed in-service training with user facility personnel on the proper loading techniques to their amsco 7052hp washer/disinfector.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee injured their hand while loading instrument racks into their amsco 7052hp washer/disinfector.The employee sought and received medical treatment at the facility's emergency room; 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 ; +1(440)259-7401
• MDR Report Key: 50073943
• Report Number: 9680353-2026-00031
• Device Sequence Number: 10216887
• Product Code: MEC
• UDI-Device Identifier: 00724995176570
• UDI-Public: (01)00724995176570(11)251203
• 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): 07/29/2026

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: 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: 06/29/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• 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