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

Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found it to be operating properly; no repairs were required and the unit was returned to service.Through follow-up discussion with user facility personnel, the technician learned that at the time of the event a rack had been improperly loaded resulting in an obstruction in the washer door.The employee was attempting to manually remove the rack when the injury occurred.Based on the technician's inspection and discussion with facility personnel, it is likely that the employee did not follow proper operating procedures for clearing an obstruction as stated in the operator manual resulting in the reported event.The reliance vision single-chamber washer/disinfector operator manual states (1), "warning personal injury and/or equipment damage hazard if an obstruction is present in the chamber door, obstruction sensor will detect obstruction and door will not close.Warning burn hazard if an obstruction is present in chamber door, do not attempt to remove the object.Door automatically raises and remains open." the operator manual further states (65), "if operator is unable to remove obstruction from chamber door, call a qualified service technician." a steris account manager will perform in-service training on the proper use and operation of the reliance vision-single chamber washer/disinfector, specifically on safe operating protocols.
Event or Problem Description
The user facility reported that an employee obtained a cut and broken bone on their hand while operating the reliance vision single chamber washer/disinfector.Medical treatment sought and administered.
Additional Manufacturer Narrative
A steris account manager offered in-service training on the proper use and operation of the reliance vision-single chamber washer/disinfector, specifically on safe operating protocols; however, the user facility declined.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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18437100
• Report Number: 9680353-2024-00002
• Device Sequence Number: 20741329
• Product Code: MEC
• UDI-Device Identifier: 00724995192686
• UDI-Public: 00724995192686
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: 12/04/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/10/2024
• 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