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	Laceration(s) (1946)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the reliance vision-single chamber washer/disinfector and found no issues with the function or operation of the device.No issues were noted with the unit's door safety switches on the loading and unloading doors.The technician tested the washer/disinfector and returned the unit to service.The reliance vision single chamber washer operator manual states (1-2), "if an obstruction is present in chamber door, do not attempt to remove the object." the technician counseled user facility personnel on the 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 an employee was manually removing an obstruction from their reliance vision-single chamber washer/disinfector when the chamber door came down and contacted the employee's hand; the employee obtained a cut.The employee sought and received medical treatment.

• 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: 16727201
• Report Number: 9680353-2023-00010
• Device Sequence Number: 7293419
• Product Code: MEC
• UDI-Device Identifier: 00724995192655
• UDI-Public: 00724995192655
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: FH05043
• 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