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

Model Number	7052HP
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an instrument rack became jammed in the door of their amsco 7052hp washer/disinfector while an employee was loading the unit.The employee attempted to free the rack manually and the door subsequently closed and contacted the employee's hand.The employee sought medical treatment which confirmed their hand was fractured; however, it is unknown what treatment medical treatment may have been administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 7052hp washer/disinfector and found a screw was loose on the door obstruction bar which caused improper alignment with the door's groove and prevented the door from raising when coming into contact with the obstruction.To resolve the issue, the technician tightened the loose screw on the obstruction bar, tested the function and operation of the unit, confirmed it to be operating to specifications, and returned it to service.The amsco 7052hp washer/disinfector subject of the reported event was installed in 2022 making it approximately 4 years old and is not under steris service agreement for preventive maintenance activities.The user facility is responsible for all maintenance activities.The following instruction is included in the preventive maintenance checklist that is supplied to the user facility for the amsco 7052hp washer/disinfector, "section 5.0; perform door safety test (displayed every 750 cycles) 4x per year." the amsco 7052hp washer/disinfector operator manual instructs the user to not attempt to manually clear door obstructions and states, "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." a steris account manager has offered to conduct in-service training with user facility personnel on the proper use and operation of their amsco 7052hp washer/disinfector, specifically, on proper preventive maintenance and loading techniques; and is pending a response.A follow-up report will be submitted when additional information becomes available.

• 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: 24535392
• Report Number: 9680353-2026-00010
• Device Sequence Number: 8933820
• Product Code: MEC
• UDI-Device Identifier: 00724995176570
• UDI-Public: (01)00724995176570(11)220307
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 02/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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