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

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Following the reported event, the sterilizer was removed from service.A steris service technician arrived onsite to inspect the sterilizer.The technician inspected the sterilizer and found the unit to be operating properly.No issues with the function or operation of the sterilizer were identified.The sterilizer was returned to service.Upon further inspection, the technician identified that the customer's drain line was the source of the reported leak.The drain line is a facility utility and is not maintained by steris.The technician advised user facility personnel that the drain line required cleaning as the drain line was backed up subsequently allowing water to drain out onto the floor.User facility personnel cleared the drain line per the technician's recommendation and no additional issues have been noted.The unit was manufactured in 2005 and is under steris service agreement for maintenance activities.

Event Description

The user facility reported that the 16" century sterilizer was leaking water onto the floor.No report of injury, procedure delay or cancellation.

• 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: 7647824
• MDR Text Key: 112850659
• Report Number: 3005899764-2018-00050
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/28/2018
• 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