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

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2020

Event Type  malfunction  

Manufacturer Narrative

Following the reported event, a steris technician arrived onsite to inspect the sterilizer and found that the v35 solenoid valve had been manually activated.Through further investigation, he learned that the valve that he had replaced during his maintenance activities was removed and replaced by user facility personnel.User facility personnel inadvertently manually activated the valve allowing steam to leak from the unit.The unit is under steris service agreement for maintenance activities; the user facility should have contacted steris to perform maintenance activities.The evolution sterilizer operator manual states (1-1)," warning - personal injury hazard and/or equipment damage hazard: repairs and adjustments to this equipment should be made only by fully qualified service personnel.Maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could cause personal injury, invalidate the warranty or result in costly equipment damage.Contact steris regarding service options." the technician replaced the air manifold, tested the unit, confirmed it to be operating according to specifications, and returned it to service.A steris account manager will offer in-service training to contact steris regarding all service activities.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported steam leaking from their 54" evolution sterilizer onto the floor.No report of injury.

Manufacturer Narrative

A steris district service manager performed in-service training on the proper use and operation of the sterilizer, specifically ensuring that personnel performing service activities be properly qualified as directed in the operator manual.The evolution sterilizer operator manual states (1-1)," warning - personal injury hazard and/or equipment damage hazard: repairs and adjustments to this equipment should be made only by fully qualified service personnel.Maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could cause personal injury, invalidate the warranty or result in costly equipment damage.Contact steris regarding service options." a 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: 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, 67190 ; MX 67190
• MDR Report Key: 11240435
• MDR Text Key: 230042111
• Report Number: 3005899764-2021-00002
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1