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

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that the vacuum pump required replacement.As the vacuum pump required replacement, this caused an excess amount of steam inside of the evolution sterilizer resulting in the reported event.The evolution sterilizer operator manual states (6-31), "steam may be released from the chamber when door is opened.Step back from the sterilizer each time the door is opened to minimize contact with steam vapor." the unit has been removed from service pending repairs.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that an employee obtained a steam burn on their face while removing a basket from their evolution sterilizer.Report of injury.Medical treatment sought and administered.

Manufacturer Narrative

The technician replaced the vacuum pump, tested the unit, confirmed it to be operating according to specifications and returned it to service.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
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 12839184
• MDR Text Key: 286063730
• Report Number: 3005899764-2021-00059
• 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,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1