MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; AMSCO 7052HP WASHER-DISINFECTOR ONTO

Model Number	7052HP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the amsco 7052hp washer-disinfector and found that the union fitting to the drain line required tightening.As the union fitting was loose it caused the drain line to rotate out of position subsequently causing water to leak out onto the floor.The technician repaired the unit, ran a test cycle, confirmed the proper use and operation and returned the amsco 7052hp washer-disinfector to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that water was leaking from their amsco 7052hp washer-disinfector onto the floor.No report of injury.
Additional Manufacturer Narrative
A steris service technician was immediately dispatched to the user facility to inspect the washer.The technician found that a fitting on the drain line became loose allowing the drain line to rotate out of position.The drain line is installed over the user facility's floor drain to direct the flow of water draining from the washer.As the drain line rotated out of position, this caused water to drain onto the floor instead of into the user facility's floor drain.The amsco 7052hp washer/disinfector operator manual states the following in the troubleshooting section (197), "7.50 water leaks from washer/disinfector general troubleshooting piping is leaking additional information 1.Verify piping is leaking, contact steris." additionally, the operator manual states (4), "warning slipping hazard to prevent slips, keep floors dry.Promptly clean up any spills or drippage." to address the issue, the technician adjusted the drain line and retightened the fitting, tested the washer, confirmed it to be operating according to specification, and returned it to service.A two-year complaint review confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: AMSCO 7052HP WASHER-DISINFECTOR ONTO
• 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: 21936629
• Report Number: 9680353-2025-00021
• Device Sequence Number: 5228520
• Product Code: MEC
• UDI-Device Identifier: 00724995176594
• UDI-Public: (01)00724995176594(11)211101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/30/2025

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: 7052HP
• Device Catalogue Number: FH18043
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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