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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" EAGLE STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 20" EAGLE STERILIZER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Burn, Thermal (2530)
Event Date 10/29/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite to inspect the 20" eagle sterilizer. The technician inspected the sterilizer and found the unit to be operating properly. No issues with the function or operation of the sterilizer was identified. While onsite, the technician learned that the user facility utilizes the machinery space behind the sterilizer as a "storage" area for non-sterilizer related stock. The employee went to retrieve an item in the machinery space and inadvertently contacted a metal component on the sterilizer as she walked by resulting in the reported event. The technician counseled facility personnel on the proper use and operation of the unit specifically, that they should avoid using the machinery space behind the sterilizer as a storage area. The unit is not under a steris service agreement for maintenance activities. The user facility is responsible for all maintenance activities. No additional issues have been reported.

 
Event Description

The user facility reported that an employee obtained a burn on the back of their wrist upon contacting the 20" eagle sterilizer. The employee did not seek any medical treatment. No report of procedure delay or cancellation.

 
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Brand Name20" EAGLE 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 Key8112332
MDR Text Key128723005
Report Number3005899764-2018-00103
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 11/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/28/2018
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?
Event Location No Information
Date Manufacturer Received10/29/2018
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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