Rappel de PlasmaJet Open Surgery Handpiece

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 Plasma Surgical 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
    61951
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1794-2012
  • Date de mise en oeuvre de l'événement
    2012-04-27
  • Date de publication de l'événement
    2012-06-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-11-01
  • 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 and coagulation accessories; devices - Product Code GEI
  • Cause
    Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use.
  • Action
    The firm, Plasma Surgical, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 27, 2012 to its Consignees/Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their physical inventory; locate and quarantine or remove from service all identified product; and complete and return the attached CUSTOMER RESPONSE FORM via fax to designated persons at: (404) 678-4395 or mail to: Plasma Surgical Inc., 1125 Northmeadow Parkway, Suite 100, Roswell, Georgia 30076 (even if they no longer have any of the product in their inventory). A Plasma Surgical Representative will contact the customers to arrange for the return of the products and product replacement, should they have any of the physical inventory (product). Should you have any queries concerning this matter, please do not hesitate to contact, Vice President of Sales and Marketing, imawhinney@plasmasurgical.com or call (678) 578-4390.

Device

  • Modèle / numéro de série
    Lot Number 40041, exp. date February 2015 and Lot Number 40043, exp. date February 2015
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA and NY; and country of: United Kingdom.
  • Description du dispositif
    PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) || The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Plasma Surgical Inc., 1009 Mansell Rd Ste F, Roswell GA 30076-4806
  • Société-mère du fabricant (2017)
  • Source
    USFDA