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

Model Number	7053L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported their amsco 7053l single-chamber washer-disinfector was leaking liquid onto the floor.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and determined the mechanical seal on the unit's circulation pump was damaged.The technician replaced the pump, confirmed the unit be operating according to specification, and returned it to service.A complaint review has determined this to be an isolated event.No additional issues have been reported.

• 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
• MDR Report Key: 21773491
• Report Number: 9680353-2025-00017
• Device Sequence Number: 15992901
• Product Code: MEC
• UDI-Device Identifier: 00724995152079
• UDI-Public: (01)00724995152079(11)190430
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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: 7053L
• Device Catalogue Number: FH41
• 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: 03/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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