MAUDE Adverse Event Report: STERIS CANADA CORPORATION TRANSFER CART 444/SYN/VISION; TRANSFER CART TO WASHER

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)

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

Event Type  No Answer Provided  

Manufacturer Narrative

The transfer carts were purchased by the user facility in (b)(6) of 2009 and are not maintained by steris.The steris account manager inspected the transfer carts and identified that on each unit, one of the transfer cart legs had separated from the cart.The account manager confirmed that both transfer carts required replacement.The damage observed on the transfer carts is indicative of improper preventive maintenance on the units.All washer accessories are the customer's responsibility to maintain.No further issues have been reported.

Event Description

The facility reported two of their transfer carts were not operating to specification causing a full rack of instruments to fall to the floor.The transfer carts were decommissioned following the event.No injury, procedural delay or cancellation was reported.

• Brand Name: TRANSFER CART 444/SYN/VISION
• Type of Device: TRANSFER CART TO WASHER
• 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: 5535465
• MDR Text Key: 41766282
• Report Number: 9680353-2016-00031
• 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: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• 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: 03/04/2016
• 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