MAUDE Adverse Event Report: STERIS CANADA CORPORATION SCS AUTOMATION

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2015

Event Type  No Answer Provided  

Event Description

The user facility reported their conveyor system's return door fell down making contact with an employee's hand.The user facility could not confirm if an injury occurred.It is unknown if the employee subject of the reported event sought or was administered medical treatment.No additional information has been provided to steris regarding the employee.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the conveyor system, and was unable to duplicate the reported event.The technician inspected the system's sensors, proximity switches, and safety bar confirming all were operating according to specification.As designed, the return door reversed when it came in contact with an object.Page 11 of the operator manual states, "warning - personal injury hazad: risk of crushing or pinching fingers or hands.Keep hands away from any moving part or baskets.".

• Brand Name: SCS AUTOMATION
• Type of Device: SCS AUTOMATION
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4518573
• MDR Text Key: 5536630
• Report Number: 9680353-2015-00020
• 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,Followup
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• 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