MAUDE Adverse Event Report: STERIS CANADA CORPORATION SCS CONVEYOR SYSTEM

Device Problem Sticking (1597)

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

Event Date 10/23/2015

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 user facility confirmed that operators had been reaching into the unit in order to dislodge the baskets.The technician adjusted the proximity sensors, tested the functionality of the conveyor system, and confirmed it to be operating according to specification.The unit was returned to service and no additional issues have been reported.The operator manual for the scs automated conveyor states, "warning - personal injury and/or equipment damage hazard: do not remove basket before unloading sequence is completed.Pulling basket out of wash chamber too soon will cause basket jam and may result in personal injury.Wait until washer door starts to close and basket is stopped at final position before removing basket." also, "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 interfaced with a reliance/hamo synergy or reliance/ hamo genfore washer, 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.

Event Description

The user facility reported that baskets on their scs motorized conveyor system were becoming stuck and required operator intervention.No report of 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: 5239991
• MDR Text Key: 32007009
• Report Number: 9680353-2015-00077
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• 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: 10/23/2015
• 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