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(s) (1757)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

No report of procedure delays or cancellations.During the reported event, an employee initiated a dart® (daily air removal test) cycle when water droplets came in contact with the employee's hand causing the reported burn.The employee was not wearing proper ppe specifically gloves.The employee sought medical treatment at the emergency department and returned to work.The 16" century sterilizer operator manual (1-1) states, "warning-burn hazard: sterilizer and rack/shelves will be hot after cycle is run.Always wear protective gloves and apron (also face shield if processing liquids) when removing a processed load.Protective gloves and apron must be worn when reloading sterilizer following previous operation." a steris service technician arrived on-site, inspected the 16" century sterilizer, and identified the s2 valve in the steam manifold assembly was not operating properly.The technician identified the s2 valve seat in the assembly was seeping water droplets into the sterilizer's chamber due to condensation.The technician replaced the unit's s2 valve seat in the steam manifold assembly, tested the unit, and returned it to service.The unit was installed at the customer's location in (b)(6) 1999 and has been in use for approximately 18 years.No additional issues have been reported.

Event Description

The user facility reported an employee obtained a burn from their 16" century sterilizer while performing a dart® (daily air removal test) cycle.

• 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6602633
• MDR Text Key: 76501051
• Report Number: 3005899764-2017-00024
• 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: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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: 05/01/2017
• 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