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

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that the brass piping connected to the sterilizer was leaking.The technician replaced the brass nipple on the piping, tested the unit, and found the unit to be operating according to specification.The unit was manufactured in 1991 and is not under steris service agreement for maintenance activities.No additional issues have been reported.

Event Description

The user facility reported that the 16" eagle sterilizer would not drain properly allowing water and steam to leak from the unit.No report of injury, procedure delay or cancellation.

• Brand Name: 16" EAGLE 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: 7700997
• MDR Text Key: 114688586
• Report Number: 3005899764-2018-00066
• 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,Followup
• Report Date: 07/18/2018

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
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 10/11/2018
• 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