Events

Recall of Device Recall da Vinci Xi EndoWrist Suction Irrigator

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
    76911
  • Event Risk Class
    Class 2
  • Event Number
    Z-1819-2017
  • Event Initiated Date
    2017-03-31
  • Event Date Posted
    2017-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154548
  • 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
    Intuitive surgical has become aware that in specific scenarios with system software p6 and the da vinci xi suction irrigator (pn 480299-03), users can experience unexpected motion of a system arm.
  • Action
    Firm sent e-mails on 3-17-17 to affected sites instructing them to STOP USE of the XI Suction Irrigator and RMA. and return all unused Xi Suction/irrigation instruments for credit. A formal letters was sent to affected sites on March 31, 2017. Letters advised of the reason for recall with details on product name and product number. Letters requested that any unused devices be returned to Intuitive via the standard RMA process. All personnel who use the Da Vinci system should be made aware of the issue. Response form should be completed online or by returning copy enclosed with the letter.

Device

Device Recall da Vinci Xi EndoWrist Suction Irrigator
  • Model / Serial
    All
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX
  • Product Description
    da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; || PN 480299-03; and || SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. || General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. The instrument tip is blunt and intended to contact tissue.
  • 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