Events

Recall of Device Recall Prostiva

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Neuromodulation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64497
  • Event Risk Class
    Class 2
  • Event Number
    Z-1031-2013
  • Event Initiated Date
    2013-02-27
  • Event Date Posted
    2013-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116347
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 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.
  • 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.

Device

Device Recall Prostiva
  • Model / Serial
    all Model 8930 radio frequency (RF) generators are affected
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.
  • Product Description
    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.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Manufacturer Address
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA