MAUDE Adverse Event Report: STERIS CANADA CORPORATION SCS AUTOMATION; ACCESSORY TO WASHER

Device Problems Component Falling (1105); Unintended System Motion (1430)

Patient Problem Injury (2348)

Event Date 09/11/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that a manifold rack moved from a conveyor belt to a transfer cart but had continued over the gate and fell onto the floor.One user facility employee moved out of the way but received cuts/scrapes on the hands from the falling manifold rack.No report of procedural delays or cancellations.

Manufacturer Narrative

The employee sought medical treatment at the employee health center for cuts/scrapes on the hands and returned to work the same day.After the washer cycle, the manifold rack transferred from the washer onto an empty scs double unload conveyor.There was only one rack on the conveyor.From the conveyor, the rack continued up and over the gate of the transfer cart.The instruments on the rack made contact with the hands of the employee and then landed on the floor.The facility's biomedical technician attempted to repair the cart but bent the transfer cart adaptor hook.The facility's biomedical technician found two pan head screws were loose and the transfer cart adaptor plate hook was bent.When attempting to repair, the facility's biomedical technician subsequently further damaged the adaptor hook.A steris field service technician arrived onsite, inspected the unit, and identified the bent hook on the transfer cart adaptor.The steris field service technician replaced the transfer cart adaptor (scs-02), tested the unit, and confirmed the unit to be operating according to specification.

• Brand Name: SCS AUTOMATION
• Type of Device: ACCESSORY TO WASHER
• 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: 4163791
• MDR Text Key: 4868289
• Report Number: 9680353-2014-00085
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• 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: 09/11/2014
• 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