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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" EAGLE STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 16" EAGLE STERILIZER Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found the source of the leak to be the sight glass valves located on the unit's steam generator. As the sight glass valves required adjustment this allowed water to leak from the sterilizer onto the floor. The technician tightened the sight glass valves, ran a test cycle, and confirmed the unit to be operating according to specification. The sterilizer was manufactured in 1993 and no additional issues have been reported.

 
Event Description

The user facility reported that the 16" eagle sterilizer was leaking water onto the floor. No report of injury, procedure delay, or cancellation.

 
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Brand Name16" 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 Key7743520
MDR Text Key116056432
Report Number3005899764-2018-00077
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 08/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/02/2018
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 Received07/06/2018
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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