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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" TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 66" TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Device Problem Component Falling (1105)
Patient Problems Pain (1994); Neck Pain (2433)
Event Date 04/17/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived at the facility following the event to inspect the transfer carriage and sterilizer. While onsite, the technician reviewed facility video footage of the event which indicates the operator attempted to latch the transfer carriage to the sterilizer with excessive force; resulting in damage to the cart's docking station. Additionally, the operator did not check that the front wheel assembly of the transfer carriage was properly latched to the docking station before withdrawing the cart from the sterilizer. The items which were removed from the sterilizer at the time of the event did not contact the floor and did not require reprocessing. The technician replaced the docking station's latching mechanism, successfully docked and undocked the transfer carriage from the sterilizer and returned the unit to service. While onsite the technician verified that all other transfer carriages located at the facility properly docked and undocked from the sterilizer(s) and did not require adjustment. The technician performed in-service training on the proper procedures for docking the transfer carriage to the sterilizer prior to removing a processed load. No additional issues have been reported.

 
Event Description

The user facility reported their 66" transfer carriage fell to the ground while an operator was removing a processed load from the sterilizer. Following the event, the operator sought medical treatment for reported neck and back pain. No injuries were evident at the time of the evaluation and the employee was advised to a week of light work duty. The employee has since returned to full work duties.

 
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Brand Name66" TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE 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 Key7522411
MDR Text Key108987535
Report Number3005899764-2018-00030
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeCA
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 05/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received04/17/2018
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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