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

Device Problem Device Handling Problem (3265)

Patient Problem Burn(s) (1757)

Event Date 06/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The instruments present during the time of the event were reprocessed before use.A steris service technician arrived onsite, inspected the sterilizer and found the unit to be operating properly.No issues were noted and the sterilizer was returned to service.No additional issues have been reported.The operator manual states (pp.3-8), "an emergency stop switch is a safety feature designed to shut the sterilizer down completely in an emergency situation." "pressing the emergency stop switch disconnects power to the door and valves, causing the door to stop and all valves to close." "important: the emergency stop switch is for emergency use only! do not use as a start/stop button." the operator manual states (pp.3-8), "warning-burn hazard: steam may be released from the chamber when the door is opened.Step back from the sterilizer each time the door is opened to minimize contact with steam vapor." the technician performed in-service training on the proper use and operation of the sterilizer with user facility personnel.

Event Description

The user facility reported that an employee accidently pressed the emergency stop switch on their sterilizer and proceeded to open the door to release the steam.The steam released and subsequently caused the employee to receive a burn on their arm.The employee sought medical treatment.

• Brand Name: 16" 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: 5791770
• MDR Text Key: 49456430
• Report Number: 3005899764-2016-00051
• 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: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• 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
• Date Manufacturer Received: 06/16/2016
• 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