MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 16" EAGLE STERILIZER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the sterilizer and found that the s3 valve had failed.The s3 valve prevents steam and water from entering the chamber of the unit.As the valve was not functioning properly, this allowed water and steam to enter the chamber of the unit subsequently causing the reported event to occur.The technician rebuilt the s3 valve, tested the unit, confirmed it to be operating according to specification, and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a burn from hot water while operating their 16" eagle sterilizer.Medical treatment was sought and administered.

• Brand Name: 16" EAGLE 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: 8552025
• MDR Text Key: 145140031
• Report Number: 3005899764-2019-00043
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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
• Date Manufacturer Received: 03/26/2019
• 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
• Patient Sequence Number: 1