MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION LOADING CART; LOADING CART TO STERILIZER

Device Problems Component Falling (1105); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

The instruments affected were reprocessed prior to use in patient procedures.The user facility stated an employee began to pull the loading cart away from the sterilizer when the loading cart became unstable and fell to the ground.A steris service technician arrived on-site, inspected the unit, and identified that the locking mechanism for the front wheels did not lock properly to the docking bracket in front of the evolution sterilizer.The technician found the docking bracket, which locks the loading cart to the sterilizer when it is loaded or unloaded, was damaged.Because the docking bracket was damaged, the front legs did not lock properly allowing the cart to become unstable and fall as it was pulled away from of the sterilizer.The steris technician replaced the docking bracket, tested the loading cart, and confirmed it to be operating according to specification.No additional issues have been reported.

Event Description

The user facility reported their 66" evolution loading cart became unstable and fell to the ground when removing a load from the sterilizer.No injury, procedure delay, or cancellation was reported.

• Brand Name: 66" EVOLUTION 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7234935
• MDR Text Key: 98876946
• Report Number: 3005899764-2018-00006
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2018
• 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