Events

Recall of da Vinci Xi Surgical System P4 software

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
    72026
  • Event Risk Class
    Class 2
  • Event Number
    Z-2734-2015
  • Event Initiated Date
    2015-08-17
  • Event Date Posted
    2015-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139598
  • 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
    Complaints regarding the exposed knife blade recoverable fault for the xi stapler with xi system p4 version software.
  • Action
    Intuitive sent an Urgent Medical Device Correction letters dated August 21, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Clinical Sales or ISI Customer service at 800-876-1310 Option 3.

Device

da Vinci Xi Surgical System P4 software
  • Model / Serial
    Model number IS4000; Affected da Vinci Xi Surgical System Serial Numbers SK0036 SK0076 SK0119 SK0156 SK0198 SK0250 SK0288 SK0342 SK0395 SK0425 SK0039 SK0077 SK0120 SK0157 SK0203 SK0254 SK0289 SK0346 SK0398 SK0433 SK0046 SK0079 SK0122 SK0159 SK0206 SK0255 SK0291 SK0347 SK0399 SK0434 SK0047 SK0081 SK0123 SK0160 SK0209 SK0257 SK0292 SK0352 SK0400 SK0437 SK0048 SK0087 SK0127 SK0161 SK0211 SK0259 SK0293 SK0356 SK0401 SK0440 SK0049 SK0091 SK0130 SK0162 SK0212 SK0262 SK0294 SK0358 SK0402 SK0441 SK0051 SK0092 SK0134 SK0163 SK0216 SK0263 SK0296 SK0359 SK0404 SK0443 SK0054 SK0093 SK0135 SK0167 SK0225 SK0264 SK0297 SK0360 SK0406 SK0445 SK0057 SK0095 SK0137 SK0168 SK0229 SK0265 SK0298 SK0366 SK0408 SK0448 SK0058 SK0096 SK0138 SK0169 SK0231 SK0266 SK0299 SK0371 SK0409 SK0451 SK0059 SK0098 SK0139 SK0171 SK0233 SK0267 SK0301 SK0375 SK0410 SK0452 SK0061 SK0099 SK0143 SK0173 SK0234 SK0269 SK0302 SK0376 SK0412 SK0455 SK0062 SK0100 SK0144 SK0175 SK0235 SK0270 SK0304 SK0378 SK0414 SK0456 SK0066 SK0101 SK0145 SK0176 SK0236 SK0271 SK0307 SK0382 SK0415 SK0459 SK0067 SK0103 SK0146 SK0178 SK0237 SK0275 SK0309 SK0383 SK0416 SK0463 SK0069 SK0106 SK0147 SK0179 SK0238 SK0276 SK0310 SK0384 SK0417 SK0464 SK0070 SK0113 SK0148 SK0180 SK0239 SK0277 SK0311 SK0385 SK0418 SK0071 SK0114 SK0150 SK0181 SK0242 SK0284 SK0314 SK0389 SK0420 SK0072 SK0115 SK0151 SK0186 SK0243 SK0285 SK0316 SK0390 SK0422 SK0074 SK0116 SK0153 SK0193 SK0245 SK0286 SK0317 SK0394 SK0423.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and in the countries of Italy and Norway.
  • Product Description
    da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : || General and Plastic surgery: || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including || grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
  • 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