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

Model Number RB3131A

Device Problems Overheating of Device (1437); Failure to Power Up (1476); Device Displays Incorrect Message (2591); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

It was reported to field service that there was an interruption in ac power at the treating facility about 15 minutes into a procedure.The control unit re-initialized after the interruption in power and staff initiated the treatment restart option.During the restart phase there was a second interruption in ac power.The unit again re-initialized and remained in the restart phase however the phase did not complete indicating that the system was not ready to recalibrate and continue treatment.At this time the coolant temperature was checked and the coolant was found to be hot to the touch.The control unit was turned off and then back on, and it displayed a coolant error message.At this point the procedure was stopped.There was no injury to the patient.After the procedure was ended field service had the technician check the control unit internal coolant level and cooling system operation in the debug mode using a coolant bag.The control unit cooling system operated without any errors in the debug mode with a coolant bag for better than fifteen minutes.

• Brand Name: TARGIS SYSTEM
• Type of Device: MICROWAVE DELIVERY SYSTEM
• Manufacturer (Section D): UROLOGIX, INC.; 14405 21st avenue n; minneapolis MN 55447
• Manufacturer (Section G): UROLOGIX, INC.; 14405 21st avenue n; minneapolis MN 55447
• Manufacturer Contact: margaret batchelder ; 14405 21st avenue n; minneapolis, MN 55447 ; 7634751400
• MDR Report Key: 4434244
• MDR Text Key: 5377057
• Report Number: 2133936-2015-00001
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: RB3131A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• 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