MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 26" EVOLUTION STERILIZER

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.

• Brand Name: 26" EVOLUTION STERILIZER
• Type of Device: STERILIZER
• 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 Key: 7538782
• MDR Text Key: 109364079
• Report Number: 3005899764-2018-00033
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/23/2018
• 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 Received: 04/25/2018
• 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