MAUDE Adverse Event Report: CORPORATION STERIS CANADA VISION; VISION MULTI-CHAMBER WASHER DISINFECTOR

Model Number	MULTI-CHAMBER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event.User facility personnel stated to the technician that an instrument tray had fallen off the rack subsequently causing the rack to become wedged in the washer.When the employee proceeded to adjust the instrument tray and rack, the door reportedly lowered and contacted their hand.The technician inspected the unit and found no issues with the function or operation and confirmed all door obstruction safety bars were operating to specifications.The unit was returned to service.The vision multi-chamber washer disinfector operator manual states, "while loading instrument racks, do not place miscellaneous articles on the sides of instrument trays.Incorrect rack loading/overloading could lead to injury and/or damage to the equipment or instruments." a steris account manager performed in-service training on the proper use and operation for the washer disinfector, specifically the proper loading techniques.No additional issues have been reported.
Event or Problem Description
The user facility reported that their vision multi-chamber washer disinfector displayed an error message indicating the door was not closing.As the employee proceeded to adjust the instrument rack inside the washer, the door lowered and contacted the employee's hand.The employee sought treatment at the er; however, it is unknown what treatment the employee may have received.

• Brand Name: VISION
• Common Device Name: VISION MULTI-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: 21663729
• Report Number: 9680353-2025-00011
• Device Sequence Number: 7694918
• Product Code: MEC
• UDI-Device Identifier: 00724995193140
• UDI-Public: (01)00724995193140(11)190220
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/21/2025

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: MULTI-CHAMBER
• Device Catalogue Number: FH82042
• 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: 02/19/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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