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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" CENTURY STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 20" CENTURY STERILIZER Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2018
Event Type  Malfunction  
Manufacturer Narrative

Procedure delays occurred as evacuations were conducted due to the reported event. A steris service technician arrived onsite and spoke with user facility personnel about the reported event. The technician confirmed that user personnel began running a dart test cycle when the sterilizer began making a "noise". No instruments were present in the cycle. The employee cancelled the cycle. After the cycle cancelled, the user facility personnel opened the sterilizer door, and steam emitted from the sterilizer causing the reported event. The technician was able to identify the root cause of the reported steam leak to be attributed to the s2 piston. The s2 piston is a valve within the steam manifold that allows steam into the chamber during operation. The technician noted there was debris built up in the steam manifold that was allowing the s2 piston to stay open subsequently allowing excess steam into the sterilizer chamber. The technician made the necessary repairs, ran a test cycle, and found the unit to be operating according to specification. No additional issues have been reported.

 
Event Description

The user facility reported that an excess amount of steam was coming from their 20" century sterilizer. The room filled with steam, activating the facility's fire alarm. No injuries were associated with the reported event.

 
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Brand Name20" 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 Key7786584
MDR Text Key117444813
Report Number3005899764-2018-00081
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 08/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2018
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 Received07/17/2018
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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