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	Pain (1994)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the reliance vision-single chamber washer/disinfector and could not duplicate the reported event.No issues were noted with the door functionality, obstruction bar or safety switches.The technician tested the washer/disinfector and returned the unit to service.While onsite, the technician learned that a user pinched their hand between a rack and the door while attempting to manually clear an obstruction from the washer door.The root cause of the event was determined as user error as the employee should not have manually cleared the obstruction from the washer door.The reliance vision single chamber washer/disinfector operator manual states (1-2), "if an obstruction is present in chamber door, do not attempt to remove the object.A door obstruction sensor detects the obstruction.Door automatically stops from closing and raises automatically.If operator is unable to remove obstruction from chamber door, call a qualified service technician." the technician counseled user facility personnel on the proper use and operation of the reliance vision-single chamber washer/disinfector, specifically on safe operating protocols.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee was manually pushing a rack into their reliance vision single-chamber washer/disinfector when the door came down and contacted their hand.The employee sought and received medical treatment (bandage) following the reported event.

• 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
• MDR Report Key: 21724094
• Report Number: 9680353-2025-00013
• Device Sequence Number: 3808919
• Product Code: MEC
• UDI-Device Identifier: 00724995192648
• UDI-Public: (01)00724995192648(11)190625
• 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): 03/28/2025

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: FH05042
• 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: 03/03/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2019
• 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