• 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. 26" 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. 26" EVOLUTION STERILIZER Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2018
Event Type  Malfunction  
Manufacturer Narrative

No report of procedure delay or cancellation. A steris service technician arrived onsite to inspect the sterilizer and found that the steel braided hose that connects the unit to the facility's water supply dislodged from the hose fitting subsequently allowing water to leak onto the floor. The steel braided hose is the facility's utility water line. At the user facility's request, the technician replaced the hose and fitting with copper piping, ran a test cycle, and found the unit to be operating according to specifications. The unit was installed at the customer's location in 2016 and no additional issues have been reported.

 
Event Description

The user facility reported that their 26" evolution sterilizer was leaking water onto the floor. No report of injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name26" 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 Key7538782
MDR Text Key109364079
Report Number3005899764-2018-00033
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 05/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/23/2018
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? No
Event Location No Information
Date Manufacturer Received04/25/2018
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

-
-