Events

Rappel de da Vinci Si" Surgical System

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 Intuitive 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
    69283
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0074-2015
  • Date de mise en oeuvre de l'événement
    2014-09-18
  • Date de publication de l'événement
    2014-10-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130164
  • 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
    System,surgical,computer controlled instrument - Product Code NAY
  • Cause
    Intuitive is issuing an urgent product notice to all users of the endowrist stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.
  • Action
    Intuitive Surgical sent an Urgent Product Notice letter dated September 19, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: -Immediately stop using the EndoWrist Stapler 45 instrument. -Quarantine the EndoWrist Stapler 45 instruments within your hospital. Keep the instruments quarantined until Intuitive Surgical sends you a subsequent communication with instructions regarding the quarantined product. -Ensure all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff, and members of your medical staff who perform da Vinci Si surgery procedures using the EndoWrist Stapler 45 instrument. -Please retain a copy of this notice for your records with your da Vinci Si User Manual. If ¿you ¿need ¿further ¿information ¿or ¿support ¿concerning ¿this ¿Product ¿Notice, ¿please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at 800-876-1310 Option ¿3 ¿(6 ¿am ¿to ¿5 ¿pm ¿PST). ¿

Device

da Vinci Si" Surgical System
  • Modèle / numéro de série
    EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution.
  • Description du dispositif
    EndoWrist Stapler 45 instrument for the da Vinci Si System || Model Number: IS3000 || Product Usage: || For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Adresse du fabricant
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Société-mère du fabricant (2017)
    Intuitive Surgical Inc
  • Source
    USFDA