MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE 1227 CART AND UTENSIL WASHER/DISINFECTOR

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found the door and unit to be operating according to specifications.There is a door stopper on the facility wall behind the door at the same level as the door holder.The user is right-handed.If the door is opened too quickly and strikes the door stopper, it could bounce back and hit the user's left arm.User facility personnel were counseled on the proper use of the reliance 1227 cart and utensil washer/disinfector, specifically for operation of the door.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee's arm was bruised from closing a reliance 1227 cart and utensil washer door while unloading a second cart.No medical treatment was sought.

• Brand Name: RELIANCE 1227 CART AND UTENSIL 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: 19286822
• Report Number: 9680353-2024-00017
• Device Sequence Number: 18047412
• Product Code: MEC
• UDI-Device Identifier: 00724995193430
• UDI-Public: 00724995193430
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/10/2024

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: 04/12/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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