MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 54" EVOLUTION STERILIZER

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2018

Event Type  Malfunction  

Manufacturer Narrative

A steris service technician arrived onsite, inspected the unit, and found evidence of a steam leak from the unit's integral steam generator. The technician identified that one of the generator's heating element coils had cracked allowing steam to leak from the unit. The steam leak damaged the unit's touch panel. The damaged heating element could result in electrical arcing. The technician replaced the unit's touch panel and heater element, tested the unit, and returned it to operation.

Event Description

The user facility reported their unit made an unusual noise and was not responding to touch panel commands. No report of injury, procedure delay or cancellation.

• Brand Name: 54" 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: 7447333
• MDR Text Key: 106252006
• Report Number: 3005899764-2018-00023
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (Y/N): N
• Reporter Country Code: CA
• 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: 04/20/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/20/2018
• 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: 03/22/2018
• 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