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 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the employee opened the door of the unit to warm up her body and hot water came in contact with her hand, resulting in a burn.The employee sought medical treatment and returned to work.A steris service technician arrived onsite following the reported event.While onsite, the technician confirmed the employee used the sterilizer as a heat source to warm up and was not wearing any ppe during the time of the reported event.The technician confirmed that a cycle was not in process during the time of the reported event.It could not be confirmed when the unit was used prior to the reported event.The century vac.Steam sterilizer's operator manual states (p.1-1), "sterilizer, rack/shelves, and loading car will be hot after cycle is run." the technician ran a cycle and found the unit to be working according to specifications.The technician counseled the user facility on proper use and operation of the century vac.Steam sterilizer.No additional issues reported.

Event Description

The user facility reported that an employee obtained a burn from their 16" century steam 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7179245
• MDR Text Key: 96970182
• Report Number: 3005899764-2018-00003
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/10/2018
• 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