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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. 60" EVOLUTION STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 60" EVOLUTION STERILIZER Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A steris service technician arrived at the facility following the event, inspected the sterilizer and found the leak originating from the unit's sight glass. The technician replaced the sight glass, tested the unit, and returned the sterilizer to service. The sterilizer was installed in june of 2016 and is currently under steris warranty. No further issues have been reported.
 
Event Description
The user facility reported their sterilizer was leaking water. No injury, procedure delay, or cancellation was reported due to the water leak.
 
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Brand Name60" EVOLUTION STERILIZER
Type of DeviceSTERILIZER
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 Key6195917
MDR Text Key63488785
Report Number3005899764-2016-00089
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 12/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2016
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 Received11/22/2016
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

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