MAUDE Adverse Event Report: STERIS CANADA CORPORATION SCS CONVEYOR SYSTEM

Device Problem Component Falling (1105)

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

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

The scs conveyor system is equipped with a transfer cart adapter.The conveyor system and transfer cart adapter were installed at the user facility's account in january of 2018 by a third-party service provider.A steris service technician arrived onsite following the event, inspected the scs conveyor system, and found that the safety pins on the conveyor system's transfer cart adapter were not raising up in position as designed to prevent the racks from falling off the conveyor belt and onto the floor.Further inspection revealed that the scs conveyor system's transfer cart adapter was not properly installed preventing the pins from reaching the required position to stop a cart from falling.While onsite, the steris technician inspected and adjusted all of the facility's scs conveyor systems, including transfer cart adapters, tested the units, and returned the units to service.The steris technician provided the third-party service installers a detailed report on the installation errors that were observed.No additional issues have been reported.

Event Description

The user facility reported an instrument rack fell from the scs conveyor system following processing in a washer.The instruments were reprocessed before use in patient procedures.No injury, procedure delay or cancellation was reported.

• Brand Name: SCS CONVEYOR SYSTEM
• Type of Device: SCS 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7554859
• MDR Text Key: 109764164
• Report Number: 9680353-2018-00044
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• 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