Recall Z-1031-2013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Medtronic Neuromodulation
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.
| Date | Apr 2, 2013 (initiated Feb 27, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 curren |
| Quantity | 848 (696 US, 152 OUS) |
| Distribution | Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113380 | PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR Medtronic, Inc., Nov 15, 2012 |