Events

Rappel de Device Recall 5X250 MM Curved Cannula, Arm 2

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
    67758
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1335-2014
  • Date de mise en oeuvre de l'événement
    2014-03-13
  • Date de publication de l'événement
    2014-04-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126240
  • 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 surgical has become aware of the potential for certain lots of the single-site 5mm curved cannulae to become damaged during use. the second part of this action is to update single-site labeling. these labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
  • Action
    Intuitive sent an Urgent Medical Device letter dated March 25, 2014, to all users of cannulas that have the potential to be damaged during use as well as a second letter to all single site cannula users that provided clarity to instruction for use for inspections and handling of the product. Certain lots manufactured prior to August of 2012, and users were asked to use Attachment A to help identify affected lots numbers. Phase 1 - Cannulas should then be inspected with information provided in Attachment B. Any damaged devices should be quarantined and returned to intuitive. If inspection does not find damage, the device may continue to be used. Any other cannulae and any non damaged product should be used according to Attachment C's instructions for use. Phase 2 - Once replacement cannulae are available, the undamaged cannulae should be returned. The Acknowledgement form should be completed and returned to Intuitive. Intuitive will contact consignees when replacement cannulae are available. Questions should be directed to Customer Service at 800-876-1310. Those consignees that use the 5 mm canulae but do not have affected product were provided with a letter that only includes the Single Site Cannula inspection and Use addendum.

Device

Device Recall 5X250 MM Curved Cannula, Arm 2
  • Modèle / numéro de série
    Part number 428072-03: Lot numbers:  VE113001 VE121005 VE121204 VE121904 VE122404 VE123008 VE113402 VE121008 VE121406 VE121906 VE122607 VE123013 VE114002 VE121104 VE121507 VE122102 VE122706 VE114402 VE121106 VE121511 VE122103 VE122905 VE120603 VE121111 VE121609 VE122301 VE122909 VE120702 VE121203 VE121708 VE122402 VE122912.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Description du dispositif
    5X250 MM Curved Cannula, Arm 2 || for use with daVinci SI Surgical System, model number IS3000. || Intuitive Surgical || 1266 Kifer Road || Sunnyvale, CA 94086 || 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, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm 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