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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. 76" FLOORLOADER STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 76" FLOORLOADER STERILIZER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 02/15/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and found that user facility personnel were not utilizing a loading cart compatible with the steris sterilizer. The technician also found that the rollers within the sterilizer required replacement due to wear. The technician replaced the rollers and confirmed the sterilizer to be operating properly. The sterilizer was returned to service and no additional issues have been reported. Steris is working with the customer for purchase of new loading carts approved for use with the subject sterilizer. The employee was not wearing gloves during the time of the reported event. The operator manual states (pp. 6-1), "warning - burn hazard: sterilizer, rack/shelves, and loading cart 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. " following the reported event, the steris technician discussed the importance of utilizing an approved loading cart with the sterilizer, and the importance of wearing ppe.

 
Event Description

The user facility reported that an employee was removing a loading cart from the sterilizer after a completed cycle when her hand slipped and contacted the inside of the sterilizer. The employee obtained a burn due to her hand contacting the sterilizer's chamber. No medical treatment was sought or administered.

 
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Brand Name76" FLOORLOADER 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 Key7346015
MDR Text Key102793592
Report Number3005899764-2018-00019
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 03/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2018
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 Received02/16/2018
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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