MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE VISION SINGLE-CHAMBER WASHER/DISINFECTOR

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their reliance vision single-chamber washer/disinfector was leaking water onto the floor causing employees to slip and fall resulting in injuries.The user facility did not disclose what medical treatment was administered.
Additional Manufacturer Narrative
A steris technician arrived onsite to inspect the unit and found the unit was leaking from the door due to a damaged door gasket.A steris account manager indicated the customer has been having issues with correctly loading their washers, which caused damage to the door gasket and the resulting water leak.The steris technician inspected the washer, replaced the gasket, tested the unit to confirm to be operating according to specification and returned to service.The steris account manager offered in-service training to the customer with an emphasis on good loading practices and safe operating protocols, however the user facility declined.The account manager forwarded the steris operator manual to the sterile processing department manager, who planned to have the staff internally review the loading and unloading references from the manual.No additional issues have been reported.

• Brand Name: RELIANCE VISION SINGLE-CHAMBER 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: 18582587
• Report Number: 9680353-2024-00006
• Device Sequence Number: 17897917
• Product Code: MEC
• UDI-Device Identifier: 00724995192686
• UDI-Public: 00724995192686
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/28/2023
• Initial Report FDA Received Date: 01/25/2024
• 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