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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 01/04/2018
Event Type  Malfunction  
Manufacturer Narrative

The employee subject of the reported event sought and received medical treatment and returned to work. A steris service technician arrived on-site, and spoke with the user facility regarding the reported event. The user facility was unable to confirm if the employee was wearing the proper ppe at the time of the event. The user facility stated the employee reached into the sterilizer to retrieve an item when water dripped on her hand causing the reported burn. The 16" century sterilizer operator manual states, "warning - burn hazard: sterilizer, rack/shelves, and loading car will be hot after cycle is run. Always wear protective gloves and apron when removing a processed load. Protective gloves and apron must be worn when reloading sterilizer following the previous operation. " the user facility also stated the sterilizer was leaking steam at the s2 valve. The technician inspected the unit, and identified the s2 and s9 valves were damaged and required replacement. The technician found that because the valves were not operating properly, steam was able to leak past the s2 valve into the sterilizer chamber, causing excess water to remain after completion of the cycle which caused the reported burn. The technician replaced the s2 and s9 valves, tested the unit, and confirmed the sterilizer to be operating according to specification. Steris will offer the user facility in-service training on the importance of using proper ppe when utilizing the 16" century sterilizer. No additional issues have been reported.

 
Event Description

The user facility reported that an employee was burned on the hand when reaching into the their 16" century sterilizer to remove a load.

 
Manufacturer Narrative

Steris offered the user facility in-service training on the proper maintenance practices and proper ppe required when using the 16" century sterilizer, however the user facility declined.

 
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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 Key7239302
MDR Text Key98988544
Report Number3005899764-2018-00008
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,Followup
Report Date 02/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/02/2018
Is This An Adverse Event 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 Received01/04/2018
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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