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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burning Sensation (2146)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

The user facility stated they had been experiencing a build-up of condensation within the sterilizer when the sterilizer door was opened.A steris service technician arrived on-site and spoke with the user facility regarding the reported event.Contrary to the reported event, the technician was able to confirm that no employee experienced a "stinging sensation" while opening the sterilizer door.The technician inspected the unit and found debris build-up in the s3 solenoid valve.To resolve the issue, the technician repaired the steam valve manifold, ran a test cycle and confirmed the unit to be operating properly.The sterilizer was returned to service and no additional issues have been reported.

Event Description

The user facility reported an employee experienced a "stinging sensation" from steam upon opening the door of their century sterilizer.No procedural delays or cancellations were reported.

• 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: 7665631
• MDR Text Key: 113628631
• Report Number: 3005899764-2018-00057
• 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: 07/05/2018

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: 06/06/2018
• Initial Date FDA Received: 07/05/2018
• 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