Events

Recall of Device Recall EndoWrist Stapler System User Manual Addendum and Wall Chart

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
    68814
  • Event Risk Class
    Class 2
  • Event Number
    Z-2171-2014
  • Event Initiated Date
    2014-06-02
  • Event Date Posted
    2014-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128783
  • 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
    Changes were made to the stapler endowrist stapler 45 system instruments and accessories user manual addendum (550986-03) and the endowrist stapler 45 wall chart (pn 551524-01) in which the ph range specification for the enzymatic cleaner used throughout the cleaning process was modified from ph-neutral to ph-neutral to mild alkaline (mild alkaline is defined as phd11). mild alkaline enzymatic.
  • Action
    Intuitive Surgical representatives hand delivered corrected manuals to the two affected sites..

Device

Device Recall EndoWrist Stapler System User Manual Addendum and Wall Chart
  • Model / Serial
    Model number 410298-05 and 410298-06
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution to Florida and South Carolina
  • Product Description
    EndoWrist Stapler System User Manual Addendum and Wall Chart; || The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing 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