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

Model Number	SINGLE CHAMBER
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch #(b)(4) that the door to their reliance vision single-chamber washer/disinfector "slammed shut after obstruction was cleared.".
Additional Manufacturer Narrative
During steris's follow-up with user facility personnel following the receipt of medwatch (b)(4) it was stated that an employee was present during the time of the reported event.The user facility reported that the washer door "fell" on the employee's hand.The employee sought medical treatment; however, the user facility did not provide information regarding any treatment received.A steris service technician was previously dispatched to the user facility on november 26, 2024, for a service request regarding the door getting stuck on the rack within the reliance vision single-chamber washer/disinfector.During the steris technician's service activity, he was not made aware of the reported incident with the employee.During the technician's inspection, he identified that the safety bar was intermittently contacting the blue handles of the rack.The technician further observed that the blue handles on the rack were damaged subsequently causing them to become out of alignment and contact the safety bar.The cause of the damaged rack handles could not be determined.The technician rebuilt the safety bar and replaced the blue handles on the rack, tested the function and operation of the reliance vision single-chamber washer/disinfector and returned the unit to service.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
• MDR Report Key: 21286131
• Report Number: 9680353-2025-00003
• Device Sequence Number: 20810444
• Product Code: MEC
• UDI-Device Identifier: 00724995192648
• UDI-Public: (01)00724995192648(11)170118
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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: 01/03/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2017
• 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