MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7052HP WASHER/DISINFECTOR

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris technician arrived onsite and confirmed water leak.Upon inspection of the unit, the technician found that the nipple on the unit's drain piping had come loose and fallen off, resulting in a water leak.The technician retightened the nipple, ran a test cycle, confirmed the unit was operating according to specifications, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported a water leak from a amsco 7052 hp washer.There was 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 the nipple on the drain line became loose and detached.The nipple is part of the drain line installed over the user facility's floor drain to direct the flow of water draining from the washer.This detachment allowed 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 retightened the nipple on the drain line, 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 7052HP WASHER/DISINFECTOR
• 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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18993055
• Report Number: 9680353-2024-00014
• Device Sequence Number: 19595873
• Product Code: MEC
• UDI-Device Identifier: 00724995176594
• UDI-Public: 00724995176594
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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