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

Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The employee should have turned off the conveyor system prior to attempting to manually move the rack.The steris operator manual states the following in accordance with personal injury and/or equipment damage hazard: "risk of crushing or pinching fingers or hands.Keep hands away from any moving part or racks.Racks, rollers and pneumatic cylinders can start in motion at any time during operation" and "in case of an emergency situation involving conveyors, depressurize conveyor line by pressing pneumatic pressure-release pushbutton on any conveyor equipped with a pneumatic cylinder.If no pressure-release pushbutton is installed, depressurize conveyor line by pressing emergency stop pushbutton on washer.If washer is not equipped with an emergency stop pushbutton, put control system power on/off switch to off." a steris service technician arrived onsite to inspect the unit and found that a bolt for the conveyer system arm was missing.As the bolt was missing, the conveyer system arm was not properly positioned to grab onto the rack and move it forward.The technician replaced the missing bolt, tested the conveyor system, confirmed it to be operating according to specifications, and returned the unit to service.The technician counseled user facility personnel on the proper use and operation of the reliance vision single-chamber washer/disinfector and conveyor system, specifically on safe operating protocols.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee noticed that a rack to their reliance vision single-chamber washer/disinfector was not moving forward on the conveyor, and they attempted to manually move the rack.The rack moved forward as the employee was pulling on it and then contacted the employee on the head.The user facility did not disclose the details of the injury or if any medical treatment was sought or administered.

• Brand Name: RELIANCE VISION SINGLE-CHAMBER WASHER DISINFECTOR
• Common Device Name: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 19679748
• Report Number: 9680353-2024-00022
• Device Sequence Number: 6851897
• Product Code: MEC
• UDI-Device Identifier: 00724995192679
• UDI-Public: 00724995192679
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/05/2024

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
• 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: 06/06/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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