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

Model Number	7052HP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	09/18/2025
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 to specifications.No repairs were required, and the unit was returned to service.The reported event is attributed to user error as the employee should not attempt to manually remove an obstruction.The amsco 7052 hp washer/disinfector operator manual states, "if an obstruction is present in the wash chamber door, the door safety bar will detect an obstruction and the door will automatically stop from closing.Wait until door is fully open before removing obstruction." additionally, the operator manual states, "if it ever occurs that the sensor does not detect a door obstruction, never use your hand to push on the obstruction trying to dislodge it.Call steris for this abnormal situation." the technician counseled user facility personnel on proper loading techniques and safety operation protocols.The amsco 7052 hp washer/disinfector is not under steris service agreement for preventive maintenance activities.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained a hand injury after removing an obstruction from the doorway of their amsco 7052 hp washer/disinfector.Medical treatment was administered.

• Brand Name: AMSCO
• Common Device Name: AMSCO 7052 HP 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: 24278958
• Report Number: 9680353-2026-00003
• Device Sequence Number: 8569466
• Product Code: MEC
• UDI-Device Identifier: 00724995176570
• UDI-Public: (01)00724995176570(11)221221
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/06/2026

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: 01/07/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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