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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. 54" EVOLUTION STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 54" EVOLUTION STERILIZER Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite, inspected the unit, and found evidence of a steam leak from the unit's integral steam generator. The technician identified that one of the generator's heating element coils had cracked allowing steam to leak from the unit. The steam leak damaged the unit's touch panel. The damaged heating element could result in electrical arcing. The technician replaced the unit's touch panel and heater element, tested the unit, and returned it to operation.

 
Event Description

The user facility reported their unit made an unusual noise and was not responding to touch panel commands. No report of injury, procedure delay or cancellation.

 
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Brand Name54" 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
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key7447333
MDR Text Key106252006
Report Number3005899764-2018-00023
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeCA
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 04/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/20/2018
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/22/2018
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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