• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 60" EVOLUTION STERILIZER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STERIS MEXICO, S. DE R.L. DE C.V. 60" EVOLUTION STERILIZER Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2017
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and found the vacuum pump located in the back of the unit had a pin size hole on the top subsequently allowing water to leak out. The technician replaced the vacuum pump, performed scheduled preventive maintenance, ran a test cycle and confirmed the sterilizer to be operating properly. The sterilizer was returned to service and no additional issues have been reported.

 
Event Description

The user facility reported that water was leaking from their sterilizer. No report of injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name60" EVOLUTION 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 Key7206298
MDR Text Key98068988
Report Number3005899764-2018-00004
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 01/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/19/2018
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 Received12/20/2017
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

-
-