MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 60" CENTURY STERILIZER

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 08/12/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived at the user facility to inspect the equipment and was unable to reproduce the reported event.The technician inspected the unit's steam to chamber valve and found the valve operating according to specification; no repairs were required.In addition, the technician performed a leak test to verify the integrity of the chamber and found the chamber seal was operational; no leaks were detected.The cycle printouts from the day of the event were retrieved and reviewed and confirmed that no cycle aborts or errors had occurred which may have contributed to the reported event.The steam sterilizer's operator manual (6-3) states, "warning- burn hazard: 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 technician additionally confirmed that the unit's steam burn warning labels were all present on the unit, advising the operator to use caution when opening the sterilizer door.The sterilizer was installed in (b)(4) 2012 and is not under a steris service contract.No further issues have been reported.

Event Description

The user facility reported that an employee was burned by steam upon opening the sterilizer door.The employee visited the facility's occupational health and was prescribed a cream to place on the affected area.The employee returned to work the same day.No procedural delays or cancellations were reported.

• Brand Name: 60" CENTURY 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5070542
• MDR Text Key: 25545928
• Report Number: 3005899764-2015-00060
• 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
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• 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