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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 Problems Fluid Leak (1250); Gas Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the units and found that the heating elements to both units were not operational allowing water and steam to leak from the sterilizers. These units were installed in 2013 making them approximately 7 years old. The technician replaced the heating elements on both units, tested the units, confirmed them to be operating according to specifications and returned them to service. No additional issues have been reported.
 
Event Description
The user facility reported water and steam leaking from two of their evolution sterilizers onto the floor. No report of injury.
 
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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 Key10871306
MDR Text Key219524189
Report Number3005899764-2020-00079
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 11/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2020
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 Received10/20/2020
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

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