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

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

Patient Problem Burn, Thermal (2530)

Event Date 12/30/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the sterilizer subject of the event.The technician ran several test cycles and confirmed the unit to be operating according to specification.No issues were identified with the function or operation of the sterilizer; no repairs were required.While onsite, the technician spoke with facility personnel regarding the reported event and learned that the employee was not wearing proper ppe during the time of the event.The reported event can be attributed to user error as the employee did not follow proper use and operation of the sterilizer.The century sterilizer operator manual states (pg.6-3), "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 counseled facility personnel on the proper use and operation of the sterilizer, wearing proper ppe, specifically gloves, and also exercising caution when opening the door after a completed cycle.No additional issues have been reported.

Event Description

The user facility reported that following a test cycle, an employee opened the sterilizer's door and obtained a burn on their thumb from a puff of steam that emitted from the chamber of their 16" century sterilizer.The employee sought medical treatment at the urgent care and returned back to work the same day.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8345519
• MDR Text Key: 137729905
• Report Number: 3005899764-2019-00014
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• 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: 01/21/2019
• 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