MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; AMSCO 7053L SINGLE-CHAMBER WASHER/DISINFECTOR

Model Number	7053L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit.User facility personnel stated to the technician that the loading cart was not properly latched to the washer causing the rack to fall.When the employee removed the rack from the washer, they did not pull the rack far enough back onto the cart for the locks to fully engage when the cart was removed from the washer's docking station.Therefore, once the cart was removed with the rack on top of it, the rack slid off the end of the cart.The employee tried to catch the rack from falling and received a laceration to their hand.The technician inspected the loading cart and confirmed it was operating properly; no repairs were required and the unit was returned to service.The instructions for use (ifu) include the following statement about proper unloading washer/disinfector, "for manual unloading of washer/disinfector (without atlas workflow automation vehicle or scs conveyor on unload side), proceed as follows: bring a transfer cart next to washer/disinfector unload door and ensure transfer cart brakes are applied (fd61-700 or fd199 for 7052hp w/d and fd179 for 7053hp w/d), ensure appropriate transfer cart wheels are locked and swiveling is not possible, ensure transfer cart is at the proper height, carefully pull accessory rack onto transfer cart and press close door to close unload door." steris counseled the user facility on the proper use and operation of the loading carts and instrument racks.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained a hand injury while unloading an instrument rack from their amsco 7053l single-chamber washer/disinfector.The employee received medical treatment.

• Brand Name: AMSCO
• Common Device Name: AMSCO 7053L SINGLE-CHAMBER 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: 22587056
• Report Number: 9680353-2025-00028
• Device Sequence Number: 9492928
• Product Code: MEC
• UDI-Device Identifier: 00724995193096
• UDI-Public: (01)00724995193096(11)190717
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/24/2025

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: 7053L
• Device Catalogue Number: FH41042
• 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: 06/27/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2019
• 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