MAUDE Adverse Event Report: CORPORATION STERIS CANADA RELIANCE VISION; WASHER/DISINFECTOR

Model Number	SINGLE CHAMBER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While onsite at the user facility, a steris installation specialist observed that user facility personnel were using a detergent during cycles which did not align with the detergent parameters set on their reliance vision single-chamber washer/disinfector.It is unknown how many instruments were processed with this detergent.No report of injury.
Additional Manufacturer Narrative
It was observed that the user facility was using prolystica hp enzymatic automated detergent (php); however, the washer's detergent parameters, including the injection rate, were set for prolystica ultra concentrate hp enzymatic detergent (puc hp).Php is less concentrated than puc hp; therefore, php requires an injection rate of 4 ml/l, but the unit was set to the injection rate of puc hp, 0.8 ml/l.Instruments processed in the reliance vision single-chamber washer/disinfector cannot be guaranteed as patient ready unless processed in accordance with the operator manual.The user facility is responsible for replacing the detergent when empty and verifying that the detergent and parameters used are aligned.The last steris preventive maintenance visit for the washers was completed in december 2025 and january 2026, at which time the detergent and parameters were aligned.The reliance vision single-chamber washer/disinfector operator manual states, "if a chemical product is low or has run out, proceed as follows: 1.Wearing appropriate personal protective equipment (ppe), remove pickup tube and low level sensor from empty container.2.Install a new chemical container.Important: never empty any remaining chemical product from the old chemical container into the new chemical container.3.Place low level sensor upright in new container.4.Insert pickup tube upright in new container.Important: do not insert pickup tube into container without verifying it is for the proper application (refer to section 3.8, chemicals and cycles for details)." to resolve the issue, the user facility switched to the puc hp detergent.User facility personnel were counseled on the proper use and operation of the reliance vision single-chamber washer/disinfector, specifically on verifying the detergent and parameters align.No additional issues have been reported.

• Brand Name: RELIANCE VISION
• Common Device Name: 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: 24698021
• Report Number: 9680353-2026-00014
• Device Sequence Number: 21449470
• Product Code: MEC
• UDI-Device Identifier: 00724995192686
• UDI-Public: (01)00724995192686(11)200120
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/26/2026

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
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2020
• 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