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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 03/13/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that an employee sustained a steam burn on his hand when reloading the sterilizer.The employee sought medical treatment and has returned to work.

Manufacturer Narrative

A steris service technician inspected the sterilizer and found it to be operating properly.No issues were noted and the sterilizer was returned to service.No additional issues have been reported.The employee was not wearing proper ppe at the time of the reported event.The operator manual states (pp.1-1), "sterilizer, rack/shelves, and loading cart 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." the operator manual further states (pp.1-1), "after manual exhaust, steam may remain inside the chamber." the technician discussed the proper use and operation of the sterilizer with hospital personnel and the importance of wearing proper ppe.The sterilizer is not under steris service contract and is serviced and maintained by the user facility.

• 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 6719 0; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4674260
• MDR Text Key: 5676387
• Report Number: 3005899764-2015-00026
• 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: 04/09/2015

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: 03/13/2015
• Initial Date FDA Received: 04/09/2015
• 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
• Patient Outcome(s): Other