MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. RENAISSANCE 3013 STEAM STERILIZER

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

Patient Problem Burn(s) (1757)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

No procedure delays or cancellations were reported.The employee obtained the burn on the top of their hand by inadvertently contacting the inside surface of their steam sterilizer while trying to load the sterilizer.The employee sought medical treatment at the user facility and did not miss any work due to the reported event.The employee was not wearing proper ppe, specifically gloves, at the time of the event.The operator manual states (pp.1), "burn hazard: washer/sterilizer and rack/shelves will be hot after cycle is run.Always wear protective gloves and apron when removing a processed load.Protective gloves and apron should also be worn when reloading washer/s terilizer following previous operation".A steris account manager was dispatched to the user facility following the reported event.The steris account manager informed the facility of the importance of wearing proper protective equipment while loading and unloading the sterilizer as specified in the unit's operator manual.The account manager also identified the loading rack shelving support had been installed backwards.The backward installation took place after the unit had been cleaned by a 3rd party company.The shelving installation has been corrected in accordance with the device specifications by the user facility.The renaissance 3013 steam sterilizer was manufactured in 2003 and is not under a steris service contract.No additional issues have been reported.

Event Description

The user facility reported an employee obtained a burn while loading a renaissance 3013 steam sterilizer.

• Brand Name: RENAISSANCE 3013 STEAM 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: 6314120
• MDR Text Key: 67264365
• Report Number: 3005899764-2017-00007
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• 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: 01/12/2017
• 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