MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. EAGLE 3000 STERILIZER

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician inspected the sterilizer and found that a copper pipe located under the sterilizer had disconnected.The copper pipe is located past the jacket trap.The steris technician stated that when the copper pipe disconnected it caused water to drip down into the sterilizer's drip pan.The drip pan accumulated water subsequently causing the water to fill the drip pan and leak out onto the floor.The steris technician replaced the copper pipe, tested the unit and confirmed the sterilizer to be operating to specifications.

Event Description

The user facility reported that water was leaking from their sterilizer.No report of injury.

• Brand Name: EAGLE 3000 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5988056
• MDR Text Key: 56543930
• Report Number: 3005899764-2016-00070
• 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: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• 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: 09/09/2016
• 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