Events

Recall of Device Recall STAPLER 45, IS4000, model number 470298

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intuitive Surgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74705
  • Event Risk Class
    Class 2
  • Event Number
    Z-2348-2016
  • Event Initiated Date
    2016-07-14
  • Event Date Posted
    2016-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148257
  • Notes / Alerts
    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.
  • Extra notes in the data
    System,surgical,computer controlled instrument - Product Code NAY
  • Reason
    An increase in the number of da vinci endowrist stapler complaints where the customer experienced a stapler firing failed message as well as review of da vinci xi surgical system logs found an increased trend.
  • Action
    Field Safety Notifications - Urgent Medical Device Corrections and Removal letters were sent on July 15, 2016 (dated July 14, 2016 advised users of the Stapler Firing Failed message and actions to take should the message be received.

Device

Device Recall STAPLER 45, IS4000, model number 470298
  • Model / Serial
    All
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.
  • Product Description
    STAPLER 45, IS4000, model number 470298 || Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection || and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Source
    USFDA