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	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported an employee experienced an injury to their hand while loading a rack of instruments into the reliance vision single chamber washer/disinfector.Medical treatment was sought.The user facility did not disclose if medical treatment was administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the reliance vision single chamber washer/disinfector and spoke to user facility personnel regarding the reported event.The technician learned that the employee was attempting to manually clear an obstruction when the door closed on their hand resulting in the reported event.The technician inspected the unit and found it to be operating properly.No repairs were required.The reliance vision single chamber washer operator manual states (1-1), "warning - personal injury hazard: risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." the operator manual further 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 specifically on safe operation protocols for the reliance vision single chamber washer/disinfector.No additional issues have been reported.

• 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 road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15464766
• Report Number: 9680353-2022-00026
• Device Sequence Number: 6864625
• Product Code: MEC
• UDI-Device Identifier: 00724995192648
• UDI-Public: 00724995192648
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/21/2022

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: 08/25/2022
• Initial Report FDA Received Date: 09/22/2022
• 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