Rappel de Device Recall JPlasma Precise 360(R)

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 Bovie Medical Corporation.

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
    79398
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1156-2018
  • Date de mise en oeuvre de l'événement
    2018-02-08
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Bovie medical is issuing a correction to address incomplete insertion of the j-plasma(r) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. the potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.
  • Action
    The firm initiated their recall on 02/08/2108 by email to distributors, and letter to the remaining consignees. Distributors were directed as follows: "We ask that you immediately: 1. Quarantine your inventory of the J-Plasma Handpieces o Provide us with a list of catalog numbers and quatities that you have on your possession using the attached Inventory List template. o Email the information to me at Rubiela.Maldonado@boviemed.com Note: as soon as we receive the information from you we will ship the box labels and insert stuffer notices for the stock that you have on your possession. o After receiving these labels, please follow the attached instructions on how to add each of the insert stuffer notice and the outer box label to each of the boxes that you have on your possession. o Document the number of labels/stuffers added to each of the products on the Inventory List provided, sign and date to confirm this was performed. o Return the signed document to me via email at Rubiela.maldonado@boviemed.com. 2. Inform your customers about the correction: o Identify and contact your customers that have received the product affected by this correction. o Provide them with a copy of the Urgent Medical Device Correction Template attached to this letter. o Track and document the customer responses to ensure 100% effectiveness. o Provide us a summary of the effectiveness of this correction (number of customers impacted and number of responses received)." The remaining consignees (users of the device) were instructed as follows: "ACTIONS: At the end of each procedure, inspect the handpiece cable plug and generator receptacle for the presence of fluids. If fluids are present, immediately discontinue use of the generator. In addition to following the J-Plasma¿ handpiece Instructions for Use, immediately begin to follow the supplemental instructions provided below to ensure that the J-Plasma¿ handpiece cable plug is properly and co

Device

  • Modèle / numéro de série
    All lots manufactured since 01/01/2014
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    worldwide
  • Description du dispositif
    J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Bovie Medical Corporation, 5115 Ulmerton Rd, Clearwater FL 33760-4004
  • Société-mère du fabricant (2017)
  • Source
    USFDA