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U.S. Department of Health and Human Services

Class 2 Device Recall Prostiva

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 Class 2 Recall
Prostiva
see related information
Date Posted April 02, 2013
Recall Status1 Terminated on November 21, 2013
Recall Number Z-1031-2013
Recall Event ID 64497
Premarket Notification
510(K) Number
K113380 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
Code Information all Model 8930 radio frequency (RF) generators are affected
Recalling Firm/
Manufacturer
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
Manufacturer Reason
for Recall
Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equi
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Medtronic sent a "Urgent Medical Device Correction" letter dated January 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Medtronic has found through device testing that if the optional footswitch (Model 60883) is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equipment. The status messages on the display screen and associated audible alarms operate as intended, and would notify the clinician of any change in status as described in chapter 2 of the system manual. Enclosed you will find an insulating cap that should be placed over the footswitch connector port when the Model 8930 RF Generator is used without the footswitch. The footswitch connector port is located on the rear panel of the Model 8930 RF Generator as shown below. For further questions In the United States, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 or your local product representative. Outside of the United States, contact your local product representative.
Quantity in Commerce 848 (696 US, 152 OUS)
Distribution Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MEDTRONIC INC.
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