Events

Recall of Device Recall EndoWrist

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
    37436
  • Event Risk Class
    Class 2
  • Event Number
    Z-0660-2007
  • Event Initiated Date
    2005-03-24
  • Event Date Posted
    2007-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50550
  • 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
    surgical instrument - Product Code NAY
  • Reason
    The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.
  • Action
    The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.

Device

Device Recall EndoWrist
  • Model / Serial
    The 8mm EndoWrist Bipolar Maryland Instrument is manufactured in lots, and traceability is maintained for each lot. A two digit unique identifier is added to the lot number label on the instruments, and programming records are traceable to these identifiers. The following 8 instruments from lot # 0503051 are affected:  0503051 66, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany.
  • Product Description
    8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, || Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 950 Kifer Rd, Sunnyvale CA 94086-5206
  • Source
    USFDA