MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 16" AMSCO 400 STERILIZER

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 12/22/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility stated the employee subject of the reported event opened the sterilizer door to place a load in the sterilizer.The door became stuck when opening and steam exited from the sterilizer burning her hand.The employee sought medical treatment at the emergency room, treatment was administered, and the employee returned to work.A steris service technician arrived on-site, inspected the unit, and identified that the steam leak was originating from a leaking s2 valve.The technician noted a slight amount of steam was leaking from the s2 valve but not enough to escape the sterilizer when the door opened as the user facility initially described.The steris technician discussed the reported event with the user facility biomed technician.The biomed technician explained that the user facility cannot confirm if the burn was caused by steam or if the employee contacted the chamber interior without gloves on.While onsite, the steris technician verified the proper operation of the amsco 400 door; no repairs were required.The technician repaired the s2 valve, tested the unit, and confirmed the sterilizer to be operating according to specification.The user facility stated the employee was not wearing proper ppe at the time of the reported event.The amsco 400 operator manual states on page 6-9, "warning - burn hazard: sterilizer, rack/shelves and loading equipment will be hot after cycle is run.Always wear protective gloves and apron when removing a processed load.Protective gloves and apron must be worn when reloading sterilizer following the previous operation.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." while on site the technician reminded the user facility personnel of the importance of proper ppe.The user facility is conducting retraining on ppe and how to load/unload the sterilizer as the steris technician could not duplicate the report of the door becoming stuck.No additional issues have been reported with the sterilizer.

Event Description

The user facility reported an employee was burned from steam which had leaked from their 16" amsco 400 sterilizer.No procedure delay or cancellation was reported.

• Brand Name: 16" AMSCO 400 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: 6265002
• MDR Text Key: 65575047
• Report Number: 3005899764-2017-00004
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• 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: 12/22/2016
• 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