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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. 16" CENTURY STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 16" CENTURY STERILIZER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Burn, Thermal (2530)
Event Date 06/08/2018
Event Type  Malfunction  
Manufacturer Narrative

The user facility was unable to provide further information on details of the event. A steris service technician arrived onsite following the reported event. While inspecting the unit, the technician found a steam leak in the s2 valve. To resolve the issue, the technician rebuilt the steam valve manifold and performed preventive maintenance activities. The technician ran a test cycle, confirmed the unit to be operating according to specifications and returned the sterilizer to service. The unit was manufactured in 2004 and no additional issues have been reported.

 
Event Description

The user facility reported that two employees were burned by steam while unloading a daily air removal test pack (dart) from a 16" century sterilizer, no instruments were present in the cycle. One of the employees sought medical treatment. No procedure delays or cancellations were reported.

 
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Brand Name16" CENTURY 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 Key7665636
MDR Text Key113559823
Report Number3005899764-2018-00058
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 07/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received06/08/2018
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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