MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; AMSCO 7053 HP 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	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the washer and found that the spray arm was damaged and the tips of the spray arm had detached.Missing spray arm tips can allow water to spray directly at the door seal resulting in the reported event.To resolve the issue, the technician replaced the spray wash arms.The technician tested the washer, found it to be operating according to specification, and returned it back to service.While onsite the user facility informed the technician that they had been running cycles with missing spray tips.The user facility was counseled on the proper use and operation of the amsco 7053 hp washer/disinfector.A three-year complaint review was performed and confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported their amsco 7053 hp washer/disinfector was leaking water resulting in procedure delays/cancellations.No report of injury.

• Brand Name: AMSCO
• Common Device Name: AMSCO 7053 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: 22805975
• Report Number: 9680353-2025-00032
• Device Sequence Number: 15719063
• Product Code: MEC
• UDI-Device Identifier: 00724995176662
• UDI-Public: (01)00724995176662(11)240227
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: 7053HP
• Device Catalogue Number: FH19042
• 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: 07/15/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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