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

Device Problem Mechanical Jam (2983)

Patient Problem Pain (1994)

Event Date 11/30/2022

Event Type  malfunction  

Event Description

The user facility reported that an employee attempted to clear an obstruction from their reliance vision multi-chamber washer/disinfector chamber while the door was closing.The door closed on the employee's arm and subsequently became stuck.The employee's arm was released, and the employee sought and received medical treatment.

Manufacturer Narrative

A steris service technician inspected the washer and found that the detection bar assembly was not present.As the detection bar was not present, this caused the washer's door to not retract subsequently causing the reported event to occur.Prior to the reported event, steris performed preventive maintenance on 11/22/2022 for the reliance vision multi-chamber washer/disinfector.During the steris technician's service activity, it was noted that the detection bar was not present.Through discussion with user facility personnel, the technician learned that they were removing the detection bar for user preference.The technician installed the detection bar and performed all preventive maintenance activities.The operator manual states, "risk of pinch point between the door and threshold when the door opens.Keep fingers away from the threshold." "if an obstruction is present in the chamber door, do not attempt to remove the object." the steris service technician counseled user facility personnel on the proper use and operation for the reliance vision multi-chamber washer/disinfector.The technician installed the detection bar assembly, tested the washer/disinfector, and confirmed the unit to be operating properly.The washer/disinfector was returned to service and no additional issues have been reported.

• Brand Name: RELIANCE VISION MULTI-CHAMBER WASHER/DISINFECTOR
• Type of Device: 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: 16062658
• MDR Text Key: 308347468
• Report Number: 9680353-2022-00034
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1