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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. 20" MILLENNIUM STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 20" MILLENNIUM STERILIZER Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and identified that the screws which secure the funnel to the pipe became loose subsequently allowing water to leak out onto the floor. The technician re-secured the screws, tested the sterilizer, and confirmed it to be operating according to specifications. The sterilizer was manufactured in 2011 and is not under steris service agreement for maintenance activities. The user facility is responsible for maintenance activities. The technician counseled the user facility on properly maintaining their sterilizer and no additional issues have been reported.

 
Event Description

The user facility reported that water was leaking from the 20" millennium sterilizer. No report of injury, procedure delay, or cancellation.

 
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Brand Name20" MILLENNIUM 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 Key7806886
MDR Text Key118254839
Report Number3005899764-2018-00083
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 08/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/22/2018
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?
Event Location No Information
Date Manufacturer Received07/24/2018
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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