MAUDE Adverse Event Report: STERIS Canada ULC AMSCO; Washer/Disinfector

Model Number	7052HP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that their amsco 7052 hp washer/disinfector was leaking water.

• Brand Name: AMSCO
• Common Device Name: Washer/Disinfector
• Manufacturer (Section D): STERIS Canada ULC; 490 boulevard armand-paris; quebec G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS Canada ULC; 490 boulevard armand-paris; quebec G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50946843
• Report Number: 9680353-2026-00039
• Device Sequence Number: 16059536
• Product Code: MEC
• UDI-Device Identifier: 00724995176594
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 08/13/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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