Events

Rappel de Prostiva RF Therapy Hand Piece Kit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Urologix, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66598
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0182-2014
  • Date de mise en oeuvre de l'événement
    2013-10-21
  • Date de publication de l'événement
    2013-11-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122692
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    A hand piece high deployment force exceeded the maximum specification.
  • Action
    Consignees were sent a Urologix Urgent Medical Device Recall letter dated October 21, 2013. The letter described the problem and the device involved in the recall. Advised consignees to examine their inventory and remove the recalled product. Requested consignees to complete and fax the "Customer Acknowledgement Form" to Hope Przybilla at 763-475-1443 or call her for questions. The consignees local representatives will be personally assisting them with the return process and ensuring that replacement product is offered and received promptly.

Device

Prostiva RF Therapy Hand Piece Kit
  • Modèle / numéro de série
    Kit Lot Number: 215251, Hand Piece Lot Number: 13E005M.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, KY, MA, MN, NC, NJ, NV, NY, OH, OR, TN, TX, and UT.
  • Description du dispositif
    Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. || The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the system provides selective thermal ablation of prostate tissue to help reduce urethral || constriction and relieve BPH voiding symptoms. || The Prostiva RF Therapy System consists of the following major components: || " Radio Frequency Generator || " Hand Piece Kit || " Telescope || The Model 8929 Prostiva RF Therapy Hand Piece Kit contains the following single-use, disposable components: || " One sterile Hand Piece with radio || frequency cable (Model 8929) || " One sterile Tubing System (Model 6101) || " One non-sterile Return Electrode (Model 8934) || The hand piece has two insulated electrode needles that deliver the radio frequency energy interstitially to the prostate. These needles are covered by insulating shields that localize the lesions within the prostate, protect the urethra from thermal damage, and eliminate collateral thermal damage. The Hand Piece stainless steel (SS) tube is inserted into the urethral canal up to the prostate with the aid of a telescope for visualization during the therapy. The Hand Piece features two insulated Nitinol needles inside the SS tube. The needles can be deployed (extended), at approximately a 90-degree angle from the SS tube, to a preset depth of between 12 mm and 22 mm (at 2 mm intervals). The needles inside the SS tube are deployed into, or retracted from the prostate, using the handle lever. RF energy is delivered through the needles to the prostate tissue. The RF energy creates molecular friction eventually resulting in tissue heating and cell death (therapy intent).
  • Manufacturer
    Urologix, Inc.

Manufacturer

Urologix, Inc.
  • Adresse du fabricant
    Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
  • Source
    USFDA