MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; 7053HP WASHER/DISINFECTOR

Model Number	7053HP
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and confirmed that the interior door glass required replacement.The technician confirmed that the glass was damaged but remained intact within the door frame.The technician replaced the door to the amsco 7053hp washer/disinfector, tested the function and operation of the unit, confirmed it to be operating to specification, and returned it to service.The operator manual states, (pg.35), "ensure no devices are sticking out or hanging out of the rack.Use a rack designed to handle the appropriate devices to be processed." steris offered in-service training on the proper use and operation of the amsco 7053hp washer/disinfector specifically, proper loading procedures and the user facility accepted.A 3-year complaint review has confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that after an employee loaded a container onto the rack in their amsco 7053hp washer/disinfector, the handle of the container was "sticking out".When the employee commanded the washer door to close, the handle contacted the door subsequently causing the interior tempered glass to break.The glass was broken in a spider-like fashion but remained intact.A user facility employee received a small cut on her hand when she contacted the door.No medical treatment was sought or administered and the employee continued working.
Additional Manufacturer Narrative
Steris performed in-service training on the proper use and operation of the amsco 7053hp washer/disinfector specifically, proper loading procedures.

• Brand Name: AMSCO
• Common Device Name: 7053HP 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: 24094388
• Report Number: 9680353-2026-00001
• Device Sequence Number: 10468708
• Product Code: MEC
• UDI-Device Identifier: 00724995176655
• UDI-Public: (01)00724995176655(11)241107
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 01/16/2026

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: 7053HP
• Device Catalogue Number: FH19072
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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