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U.S. Department of Health and Human Services

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

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION LOADING CART LOADING CART TO STERILIZER Back to Search Results
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.

 
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Brand Name66" EVOLUTION LOADING CART
Type of DeviceLOADING 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 Key7234935
MDR Text Key98876946
Report Number3005899764-2018-00006
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received02/01/2018
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
Event Location No Information
Date Manufacturer Received01/11/2018
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

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