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

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

The user facility reported an obstruction in the reliance vision single-chamber washer disinfector which caused a rack to jam in the washer door.An employee attempted to manually adjust an instrument on the rack to clear the obstruction.When the obstruction was cleared from the door the washer's door quickly closed and contacted the employee's hand.The employee went to the er and was administered medical treatment and missed a few days of work as a result of the injury.

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the washer.The technician inspected the washer, found no issue with the function of the unit or its door obstruction safety mechanism on the load and unload sides.There were no repairs/adjustments required, the unit was tested, confirmed to be operating according to specification, and returned to service.Additionally, the door obstruction detection assemblies were tested during the last preventive maintenance 9/14/2022, and they were found to conform to specifications.The reported event is attributed to user error as the employee should not have stuck their hand in the washer as the door was closing.The reliance vision single chamber washer operator manual (pg.1-1) states, "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.Wait until water flow has stopped before removing an obstruction." the operator manual further states, "warning personal injury hazard risk of pinch point between door and upper panel.Do not push on top portion of doors; do not push on door when door is rising; do not push on door when door is jammed." the service technician counseled o the user facility personnel on safe operating protocols of the reliance vision single chamber washer.No additional issues have been reported.

• Brand Name: RELIANCE VISION SINGLE 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: 16033803
• MDR Text Key: 308394530
• Report Number: 9680353-2022-00032
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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: 12/02/2022
• 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