MAUDE Adverse Event Report: STERIS CANADA CORPORATION SCS CONVEYOR SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 02/15/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Upon the arrival of the steris service technician he was made aware that an employee had obtained an injury.The technician was advised that an employee had attempted to lift the door open when the door came back down pinching the fingers of the employee.The user facility did not disclose whether the employee sought or received medical treatment.The steris service technician inspected the conveyor system and found that a screw and spring on the safety bar were missing.The technician repaired the conveyor system, ran a test cycle and confirmed the unit to be operational.No additional issues have been reported.The operator manual states (pp.1-2), "risk of pinch point between door and threshold when door opens.Keep fingers away from threshold." "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 preventive maintenance checklist states to inspect for air leaks and motorized return door 4 x per year.The conveyor system was manufactured in 2014 and is serviced and maintained by the user facility.

Event Description

The user facility reported that the pass through window on their conveyor system was not operating properly which resulted in an employee injury.

• Brand Name: SCS CONVEYOR SYSTEM
• Type of Device: CONVEYOR SYSTEM
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5493413
• MDR Text Key: 40306011
• Report Number: 9680353-2016-00018
• 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
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2016
• 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