MAUDE Adverse Event Report: CORPORATION STERIS CANADA VISION; RELIANCE VISION 1327 CART AND UTENSIL WASHER/DISINFECTOR

Model Number	1327
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their reliance vision 1327 cart and utensil washer/disinfector leaked steam and water onto the floor.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and learned that during the time of the reported event, the 1327 cart and utensil washer/disinfector alarmed "chamber pressure abnormal." the employee who heard the alarm, did not follow the general troubleshooting activities outlined in the reliance 1327 operator manual as they activated the e-stop button prematurely stopping the cycle before the drying phase was initiated.After the e-stop button was pressed, the employee opened both doors to the unit resulting in the reported event.The 1327 cart and utensil washer/disinfector operator manual states, "press alarm reply on touch screen to stop alarm buzzer and acknowledge displayed alarm message, abort cycle, if condition reoccurs, contact steris." while onsite, the technician found that the shaft of the pneumatic cylinder was damaged.The pneumatic cylinder controls the drying air distribution within the unit's drying damper.As the cylinder was damaged, the drying damper did not open when the exhaust and drying fans were activated resulting in the reported excess steam.The technician replaced the pneumatic cylinder, exhaust vent, and drying damper.The unit was tested, confirmed to be operating according to specification, and returned to service.The1327 cart and utensil washer/disinfector is not under a steris service agreement for preventive maintenance activities; the user facility is responsible for all maintenance activities.The technician counseled user facility personnel on the proper use and operation of the 1327 cart and utensil washer/disinfector, specifically the importance of following the process outlined in the operator manual.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: VISION
• Common Device Name: RELIANCE VISION 1327 CART AND UTENSIL 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 ; 4402597401
• MDR Report Key: 22819936
• Report Number: 9680353-2025-00033
• Device Sequence Number: 14900706
• Product Code: MEC
• UDI-Device Identifier: 00724995193515
• UDI-Public: (01)00724995193515(11)210831
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: 1327
• Device Catalogue Number: FW05201
• 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: 07/16/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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