MAUDE Adverse Event Report: STERIS CANADA CORPORATION SCS AUTOMATED CONVEYER; WASHER ACCESSORY

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Bruise/Contusion (1754)

Event Date 02/26/2014

Event Type  No Answer Provided  

Event Description

The user facility reported a screw on the return door safety bar had fallen out causing the safety bar to drop down on one side.The facility attempted to tape the safety bar back into place; however the plastic safety bar again fell and bruised an employee's arm.No procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived at the facility, inspected the scs conveyer and found the safety bar taped into position.The technician identified that the tape applied by the user facility interfered with the unit's door sensor causing the door to remain open and disabling the unit's motorized rollers.The technician was informed that the employee had attempted to manually push the carts through the automated pass through window when the safety bar dropped down on one side, bruising the employee's arm.The steris technician asked to speak with the injured employee; however the employee was reported to be on leave in relation to her injury.Steris has made multiple attempts to obtain additional information regarding the employee's injury however the facility has been unresponsive.Section 4.1.2 of the scs operator manual states, "conveyor don'ts - never transport rack sideways on a two-way conveyor in front of washer unload door while it is opening or opened." additionally, the operator manual instructs the user facility to contact steris if an issue occurs.The operator manual states, "if you are unable to correct the problem with use of the troubleshooting chart, or if a problem occurs that is not described on chart, call steris." additional in-service training was offered to the user facility, however the facility declined.The technician applied thread lock on the screw, put the spring that recoils the safety bar in place and tightened the screw to specification.The technician performed a test cycle, confirmed the device was operating to specification and returned the unit to service.The scs was installed in (b)(6) 2013 and is currently under steris warranty.

• Brand Name: SCS AUTOMATED CONVEYER
• Type of Device: WASHER ACCESSORY
• 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: 3689366
• MDR Text Key: 4243537
• Report Number: 9680353-2014-00024
• 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: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• 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: 02/26/2014
• 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