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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. 60" CENTURY STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 60" CENTURY STERILIZER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 06/11/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris technician arrived onsite and spoke with user facility personnel regarding the reported event. The technician was informed that following a completed cycle, the employee attempted to open the sterilizer's door and noticed that the door seal was "sticking". The employee forcefully pulled on the door causing the seal to protrude from the door channel. As the seal was coming out of the door channel, the employee used a towel to attempt to place the seal back into the door channel resulting in the reported burn. The employee should not have touched the sterilizer's door seal following a processing cycle as stated in the operator manual. The 60" century sterilizer operator manual states (pg. 1-1), "warning- burn hazard: allow sterilizer to cool to room temperature before performing any cleaning or maintenance procedures. " additionally, the employee was not wearing proper ppe. The operator manual states (pg. 5-6), "warning - burn hazard: sterilizer, rack/shelves, and loading car will be hot after cycle is run. Always wear protective gloves. " the steris technician replaced the door seal, tested the unit, and found the sterilizer to be operating according to specification. The unit was installed at the customer's location in june of 2006 and is under steris service agreement for maintenance activities. No additional issues have been noted.

 
Event Description

The user facility reported that an employee obtained a burn on their arm upon contacting the door seal of the 60" century sterilizer. The employee did not seek medical treatment and did not miss any work. No report of procedure delay or cancellation.

 
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Brand Name60" 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 Key7679290
MDR Text Key113956197
Report Number3005899764-2018-00059
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 07/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2018
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 Received06/11/2018
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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