MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 60" ATLAS LOADING CART; LOADING CART TO STERILIZER

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/01/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The facility reported that when removing a rack from the sterilizer using the loading cart, the wheels on the cart began to "tilt" and "slip out" causing the rack to nearly fall off of the loading cart.The loading cart as been in use since 2009 and is not under a steris service contract.A steris service technician inspected the loading cart and found that three of the swivel wheels had worn rubber blocks and required replacement.The technician recommended the facility replace the worn wheels and periodically inspect the swivel wheels to ensure they are operating to specification.No further issues have been reported.

Event Description

The user facility reported that the wheels on their atlas loading cart do not operate to specification.

• Brand Name: 60" ATLAS LOADING CART
• Type of Device: LOADING CART TO STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5491723
• MDR Text Key: 40274501
• Report Number: 3005899764-2016-00020
• Device Sequence Number: 1
• Product Code: FLE
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/10/2016
• 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