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

Model Number	Single Chamber
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility has three reliance vision single chamber washer/disinfectors.However, it is unknown which of the units is subject of the reported event.A steris service technician arrived onsite to inspect all three units and found them to be operating according to specification.The technician also found no issues with the function of the door safety switches.No repairs were required, and the units were returned to service.The reported event is attributed to user error as the employee did not follow proper instructions as stated in the operator manual.The reliance vision single chamber washer operator manual states (1-2), "warning: if an obstruction is present in chamber door, do not attempt to remove the object." the technician counseled user facility personnel on 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 during the automated load process, a rack was not completely inserted into their reliance vision single chamber washer/disinfector.An employee pushed the rack into the chamber, and the washer door came down on the employee's fingers.Medical treatment was sought and 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: 16724708
• Report Number: 9680353-2023-00009
• Device Sequence Number: 15441257
• Product Code: MEC
• UDI-Device Identifier: 00724995192648
• UDI-Public: 00724995192648
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 04/12/2023

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: 03/14/2023
• Initial Report FDA Received Date: 04/12/2023
• 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