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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 Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 11/03/2020
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the pressure switch was damaged causing water and steam to leak from their sterilizer.While onsite the technician replaced the pressure switch, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.
 
Event Description
The user facility reported water and steam were leaking from their evolution sterilizer onto the floor.No report of injury.
 
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Brand Name
EVOLUTION STERILIZER
Type of Device
STERILIZER
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 Key10936643
MDR Text Key219524058
Report Number3005899764-2020-00083
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 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
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
Date Manufacturer Received11/03/2020
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 Number1
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