MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; 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	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the unit and found that the spray arms to the washer's racks were damaged subsequently causing them to disconnect.Due to the spray arms disconnecting, this allowed water to directly spray towards the door seal subsequently causing water to leak from the unit and onto the floor.The technician repaired the amsco 7053 hp washer/disinfector manifold racks, ran a test cycle, confirmed the unit to be operating to specifications and returned the devices to service.The damage to the spray arms may be attributed to user facility personnel contacting the arms during loading or unloading of the racks.The damage may also be attributed to improper cleaning practices by user facility personnel.The operator manual states (pg.159), "once a week, clean chamber rotary spray arm assemblies.If necessary, repeat appropriate cleaning procedure for each rotary spray arm assembly on manifold racks." user facility personnel were counseled on the importance of not contacting the spray arms during loading/unloading and weekly cleaning activities.No additional issues have been reported.
Event or Problem Description
The user facility reported that water was leaking from their amsco 7053 hp washer/disinfector onto the floor.No report of injury.

• 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 ; 4402597401
• MDR Report Key: 22965137
• Report Number: 9680353-2025-00037
• Device Sequence Number: 9137784
• Product Code: MEC
• UDI-Device Identifier: 00724995176655
• UDI-Public: (01)00724995176655(11)250116
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/04/2025

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: 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: 08/06/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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