Events

Rappel de Curved Needle Driver

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
    72036
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2757-2015
  • Date de mise en oeuvre de l'événement
    2015-08-08
  • Date de publication de l'événement
    2015-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139636
  • 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
    In certain circumstances involving select da vinci si single-site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
  • Action
    Intuitive Surgical sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Ensure that 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 Surgery procedures. 2. Replace any instrument that shows signs of damage and contact Intuitive Surgical Customer Service. 3. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 4. Please retain a copy of this notice as well as the attached instructions with your Single-Site User Manual. If you need further information or support concerning this issue, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: ¿ North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com ¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com ¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) ¿ Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST) For questions regarding this recall call 408-523-2100.

Device

Curved Needle Driver
  • Modèle / numéro de série
    Model numbers: 428088-12, 428088-13; all lots
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
  • Description du dispositif
    Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); || Model numbers: 428088-12, 428088-13. || The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
  • 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