Events

Recall of TIP COVER ACCESSORY

According to Health Canada (via FOI), this recall involved a device in Canada 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
    130149
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    During the manufacturing process to package each tip cover each part is placed into the top open end of a rectangular pre-made pouch which is sealed along the sides and bottom edges. to seal the pouch containing the product the open end edge is clamped and sealed by applying heat and pressure creating a closed seal impressed with a thatched pattern. it has been found with a small number of the pouches manufactured when creating the closure the sealed edge was not uniform and pleats or creases were formed within the seal area of the pouch. of those non-uniform seals in a small percentage of these seals these pleats or creases may breach the seal barrier integrity.

Device

TIP COVER ACCESSORY
  • Model / Serial
    Model Catalog: 400180 (Lot serial: Contact manufacturer.); Model Catalog: 400180 (Lot serial: >10 lot numbers.)
  • Product Description
    8MM Tip Cover Accessory
  • Manufacturer
    INTUITIVE SURGICAL INC.

Manufacturer

INTUITIVE SURGICAL INC.