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 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

No procedure delays or cancellations were reported.Following the reported event, the employee sought and received medical treatment at the user facility and returned to work.It is unknown by user facility personnel if the employee subject of the event was wearing proper ppe during the time of the reported event as stated in the operator manual.The operator manual states (pp.1-1), "after manual exhaust, steam may remain inside the chamber.Always wear protective gloves, apron, and a face shield when following emergency procedure to unload sterilizer.Stay as far back from the chamber opening as possible when opening the door".A steris service technician arrived onsite to inspect the 16" century sterilizer.The technician ran a test cycle and identified that the s2 valve in the steam manifold assembly was not operating properly.The technician rebuilt the s2 valve located in the assembly, tested the unit, and confirmed that the 16" century sterilizer was operating properly.The unit was manufactured in 2009 and is under steris service agreement.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a burn on the back of their arm while removing a load after a completed cycle in their 16" century sterilizer.

• 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: 6687685
• MDR Text Key: 79250581
• Report Number: 3005899764-2017-00030
• 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: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• 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: 06/09/2017
• 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