MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 20" CENTURY STERILIZER

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

Procedure delays occurred as evacuations were conducted due to the reported event.A steris service technician arrived onsite and spoke with user facility personnel about the reported event.The technician confirmed that user personnel began running a dart test cycle when the sterilizer began making a "noise".No instruments were present in the cycle.The employee cancelled the cycle.After the cycle cancelled, the user facility personnel opened the sterilizer door, and steam emitted from the sterilizer causing the reported event.The technician was able to identify the root cause of the reported steam leak to be attributed to the s2 piston.The s2 piston is a valve within the steam manifold that allows steam into the chamber during operation.The technician noted there was debris built up in the steam manifold that was allowing the s2 piston to stay open subsequently allowing excess steam into the sterilizer chamber.The technician made the necessary repairs, ran a test cycle, and found the unit to be operating according to specification.No additional issues have been reported.

Event Description

The user facility reported that an excess amount of steam was coming from their 20" century sterilizer.The room filled with steam, activating the facility's fire alarm.No injuries were associated with the reported event.

• Brand Name: 20" 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: 7786584
• MDR Text Key: 117444813
• Report Number: 3005899764-2018-00081
• 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: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• 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: 07/17/2018
• 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