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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. ATLAS TRASFER CARRIAGE TRASFER CARRIAGE TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. ATLAS TRASFER CARRIAGE TRASFER CARRIAGE TO STERILIZER Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Burn(s) (1757)
Event Date 10/17/2016
Event Type  No Answer Provided  
Manufacturer Narrative
Steris does not manufacturer or distribute a tool as the facility described to assist in unloading carts from our sterilizer. Following notification of the event, a steris account manager contacted the user facility for additional information. The user facility stated that an employee's arm inadvertently touched the transfer carriage while removing the carriage from a steam sterilizer causing the burn. The user facility stated the atlas transfer cart is functioning per specification. Per discussion with the employee subject of the event and facility supervisors, this event was found to be the result of user error. The atlas transfer carriage operator manual states on page 1-1, "warning - burn hazard: sterilizer and loading car will be hot after cycle is run. Always use hand protection and apron (also face shield if processing liquids) when removing a processed load. Hand protection and apron must be worn when reloading sterilizer following the previous operation. " the steris account manager, along with the employee's supervisor, instructed facility personnel on the importance of using caution, and correct ppe, when removing the transfer carriage from the sterilizer.
 
Event Description
The user facility contacted steris through a website forum inquiring as to whether steris sells a tool to assist personnel when removing a transfer carriage from a steam sterilizer. The user indicated that she was looking for this tool as an employee received a burn when removing the transfer carriage from the steam sterilizer.
 
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Brand NameATLAS TRASFER CARRIAGE
Type of DeviceTRASFER 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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key6106574
MDR Text Key60440859
Report Number3005899764-2016-00080
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 11/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2016
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 Treatment Data
Date Received: 11/16/2016 Patient Sequence Number: 1
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