MAUDE Adverse Event Report: CORPORATION STERIS CANADA RELIANCE VISION; RELIANCE SINGLE-CHAMBER WASHER DISINFECTOR

Model Number	SINGLE CHAMBER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that water was leaking from their reliance vision-single chamber washer/disinfector onto the floor.No report of injury.
Additional Manufacturer Narrative
The reliance single-chamber washer disinfector is not under steris service contract for preventive maintenance; the user facility is responsible for maintenance activities.The user facility stated that their device is serviced and maintained by a third-party service provider (getinge).Following the reported event, a getinge service technician inspected the unit and found that water was leaking from the front seal of the unit's recirculation pump.The getinge technician replaced the pump front seal, ran a test cycle, confirmed the unit to be operating to specification, and returned it to service.Steris was not contacted for service following the reported event and has not been contacted for service since 2021.No additional issues have been reported.

• Brand Name: RELIANCE VISION
• Common Device Name: RELIANCE SINGLE-CHAMBER 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
• MDR Report Key: 20791843
• Report Number: 9680353-2024-00040
• Device Sequence Number: 20514871
• Product Code: MEC
• UDI-Device Identifier: 00724995192686
• UDI-Public: (01)00724995192686(11)191202
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2024

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
• Device Model Number: SINGLE CHAMBER
• Device Catalogue Number: FH05072
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/27/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2019
• 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