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

Model Number	7053HP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported their amsco 7053hp washer was leaking water onto the floor.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the washer and found that the user facility was overloading items on it which caused the spray nozzles to detach from the spray arms on the rack.The amsco 7053hp washer-disinfector operator manual states: "always position manifold rack over the manifold connector before operating washer/disinfector.If manifold rack and/or bottom rotary spray arm assembly are not positioned correctly, damage may result and washer/disinfector will be unable to effectively wash load." to resolve the issue, the technician replaced the spray wash arms and tightened the spray nozzles.The technician tested the washer, found it to be operating according to specification, and returned it to service.Steris will offer counseling to user facility personnel on the proper use of their amsco 7053hp washer-disinfector no additional issues have been reported.
Additional Manufacturer Narrative
Steris offered in-service training on the proper use and operation of the amsco 7053 hp washer/disinfector, however the user facility declined.

• Brand Name: AMSCO
• Common Device Name: AMSCO 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
• MDR Report Key: 22021695
• Report Number: 9680353-2025-00022
• Device Sequence Number: 15657151
• Product Code: MEC
• UDI-Device Identifier: 00724995176679
• UDI-Public: (01)00724995176679(11)240207
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7053HP
• Device Catalogue Number: FH19043
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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