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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. EAGLE STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. EAGLE STERILIZER Back to Search Results
Device Problem Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2018
Event Type  Malfunction  
Manufacturer Narrative

All instruments subject of the reported event were reprocessed prior to use. A steris service technician arrived onsite following the reported event to inspect the sterilizer and found that the solid state relay was damaged. The solid state relay is an electrical switch located in a box on the side of the unit. The technician replaced the solid state relay, tested the sterilizer, and found the unit to be operating according to specification. The sterilizer was returned to service. The eagle sterilizer was installed in 2001 making the unit approximately 17 years old and is not under steris service agreement for maintenance activities. A 3-year complaint review indicates this to be an isolated event and no additional issues have been reported.

 
Event Description

The user facility reported that their eagle sterilizer began to smoke. No report of injury or inhalation/irritation.

 
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Brand NameEAGLE 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 Key8139386
MDR Text Key129622991
Report Number3005899764-2018-00106
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 12/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/06/2018
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 Received11/15/2018
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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