MAUDE Adverse Event Report: STERIS CANADA CORPORATION SCS AUTOMATED CONVEYOR SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/03/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the system, and identified the proximity sensors required adjustment.Additionally the technician was notified that operators would intervene to ensure a proper transition of the baskets on the conveyor system.The operator manual for the scs automated conveyor states, "warning - personal injury and/or equipment damage hazard: conveyors are never turned off unless conveyor power supply on/off switch or building circuit breaker is in off position." additionally, "warning - personal injury hazard: risk of crushing or pinching fingers or hands.Keep hands away from any moving part or baskets.Baskets, rollers, feed-in cylinders and feed-out cylinders can start in motion at any time during operation." "in case of an emergency situation involving conveyors.Depressurize scs load/unload conveyors by pressing emergency stop pushbutton on washer." steris has reviewed the operator manual warnings with the user facility to ensure proper use and operation of the conveyor system.A follow-up report will be submitted if additional information becomes available.

Event Description

The user facility reported that the sensors on their scs automated conveyor system were not operating properly.As a result, user facility operators have to manually move fully loaded instrument racks on the conveyor.No report of injury.

• Brand Name: SCS AUTOMATED 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: 5320787
• MDR Text Key: 34808051
• Report Number: 9680353-2015-00089
• 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: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/03/2015
• 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