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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. EVOLUTION STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. EVOLUTION STERILIZER Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem Burn(s) (1757)
Event Date 10/20/2021
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the vacuum pump required replacement. As the vacuum pump required replacement, this caused an excess amount of steam inside of the evolution sterilizer resulting in the reported event. The evolution sterilizer operator manual states (6-31), "steam may be released from the chamber when door is opened. Step back from the sterilizer each time the door is opened to minimize contact with steam vapor. " the unit has been removed from service pending repairs. A follow-up mdr will be submitted when additional information becomes available.
 
Event Description
The user facility reported that an employee obtained a steam burn on their face while removing a basket from their evolution sterilizer. Report of injury. Medical treatment sought and administered.
 
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Brand NameEVOLUTION STERILIZER
Type of DeviceSTERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key12839184
MDR Text Key286063730
Report Number3005899764-2021-00059
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,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2021
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
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2011
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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