MAUDE Adverse Event Report: UROLOGIX, INC. TARGIS SYSTEM; MICROWAVE DELIVERY SYSTEM FOR BPH.

Model Number 410097-001

Device Problem Leak/Splash (1354)

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

Event Date 05/30/2014

Event Type  malfunction  

Event Description

It was reported that a small leak was discovered at the bottom of the coude tip.The treatment was completed successfully.

Manufacturer Narrative

The evaluation showed that the location balloon had a small leak due to either an incomplete fill, void, or air bubbles in the adhesive.

• Brand Name: TARGIS SYSTEM
• Type of Device: MICROWAVE DELIVERY SYSTEM FOR BPH.
• Manufacturer (Section D): UROLOGIX, INC.; 14405 21st avenue north; minneapolis MN 55447
• Manufacturer (Section G): UROLOGIX, INC.; 14405 21st avenue n.; minneapolis MN 55447
• Manufacturer Contact: margaret batchelder ; 14404 21st avenue n.; minneapolis, MN 55447 ; 7634751400
• MDR Report Key: 3901948
• MDR Text Key: 20659018
• Report Number: 2133936-2014-00003
• Device Sequence Number: 1
• Product Code: MEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2014

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
• Device Expiration Date: 09/01/2015
• Device Model Number: 410097-001
• Device Catalogue Number: 410097-001
• Device Lot Number: 130926MCA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1