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

Model Number	SINGLE CHAMBER
Medical Device Problem Codes	Unintended Movement (3026); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Insufficient Information (4580)
Date of Event	06/18/2025
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 an employee was injured while using their reliance vision-single chamber washer/disinfector.No further details have been provided at this time.
Additional Manufacturer Narrative
Through follow-up with the user facility, steris learned that at the time of the event the employee was testing the washer and selected the close door button.The employee became distracted by an alarm and did not remove their arm from the path of the door as it closed resulting in the reported injury.A steris service technician arrived onsite to inspect the washer and found that the safety bar for the door was broken.The technician replaced the door assembly and safety bar, tested the unit, confirmed it to be operating according to specification, and returned it to service.The technician counseled user facility personnel on the proper use and operation of the washer, specifically to keep away from the door while opening and closing.No additional issues have been reported.

• Brand Name: RELIANCE VISION
• Common Device Name: RELIANCE VISION-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 ; 4402597401
• MDR Report Key: 22540616
• Report Number: 9680353-2025-00027
• Device Sequence Number: 18259767
• Product Code: MEC
• UDI-Device Identifier: 00724995192655
• UDI-Public: (01)00724995192655(11)160212
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/18/2025

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: FH05043
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2016
• 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