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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 Patient-Device Incompatibility (2682)
Patient Problem Burning Sensation (2146)
Event Date 06/06/2018
Event Type  Malfunction  
Manufacturer Narrative

The user facility stated they had been experiencing a build-up of condensation within the sterilizer when the sterilizer door was opened. A steris service technician arrived on-site and spoke with the user facility regarding the reported event. Contrary to the reported event, the technician was able to confirm that no employee experienced a "stinging sensation" while opening the sterilizer door. The technician inspected the unit and found debris build-up in the s3 solenoid valve. To resolve the issue, the technician repaired the steam valve manifold, ran a test cycle and confirmed the unit to be operating properly. The sterilizer was returned to service and no additional issues have been reported.

 
Event Description

The user facility reported an employee experienced a "stinging sensation" from steam upon opening the door of their century sterilizer. No procedural 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 Key7665631
MDR Text Key113628631
Report Number3005899764-2018-00057
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? 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 Received06/06/2018
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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